Global Regulatory Monitor Regulatory News, Week 2 · 2026/8
Period 2026-08-03 ~ 2026-08-10Published 2026-08-10Collected 83 · 26 cardsEvidence A 15 · B 11 · C 0
10 cards in this issue cover Korean regulator documents. Company and institution names, and quoted source text, are shown in Korean exactly as they appear on the official record.
This week's key points
FDA issues a warning letter to Dabur India over data integrity violations including a falsified equipment use log
Rohto-Mentholatum in Vietnam recalls eight eye drop products for lack of assurance of sterility
MFDS suspends manufacture of a herbal product for three months after ash and acid-insoluble ash failed specification
About AI-generated content
Summaries, translations, implications, check items, and in-depth analysis are written by generative AI; figures, quotations, links, and machine-extracted tables are provided as in the source. This is reference material — check the official source before making decisions.
[Warning Letter · FDA]Woodbine Products Company Inc. — No identity testing of high-risk components
Evidence BFDASignal High · T3CGMP
FDA issued a warning letter to the OTC drug site of Woodbine Products Company Inc. for failure to test the identity of incoming components, absence of process and cleaning validation, and failure of quality unit oversight.
Published
2026-08-04
Document no.
03dfb7e91f6b
Company / site
Woodbine Products Company Inc.
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 07/27/2026
Key facts · Basis: official index plus supporting sources
Violation 1: incoming components such as glycerin, propylene glycol and ethanol were not identity tested lot by lot, and non-pharmaceutical grade propylene glycol was used (21 CFR 211.84(d)(1))
Violation 2: no process performance qualification and no process monitoring programme, and no cleaning validation for non-dedicated equipment (21 CFR 211.100(a))
Violation 3: the quality unit did not hold test specifications, batch release testing, a stability programme or batch records (21 CFR 211.22)
Action: written response within 15 working days, test results for DEG, EG and alcohol impurities within 30 days of the letter, and a CGMP consultant recommended given the repeat violations
Insight · Editorial insight
FDA is treating lot-by-lot identity testing of components at risk of diethylene glycol and ethylene glycol contamination, and of methanol in ethanol, as a top enforcement priority. Sites that substitute a supplier certificate of analysis for their own component testing should re-examine the scope of compendial identity testing they perform and the evidence supporting supplier reliability.
Check points
Whether compendial identity testing is performed lot by lot on high-risk components such as glycerin and propylene glycol
Records of testing for methanol in ethanol and for the impurities in the relevant monographs
Basis for initial validation and periodic revalidation of supplier certificate reliability
Violation detail · 3 items · From the source
Violation 121 CFR 211.84(d)(1)
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).
Violation 221 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
Violation 321 CFR 211.22
Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
[Warning Letter · FDA]Dabur India Limited — Falsified equipment log, data integrity
Evidence BFDASignal High · T3CGMP
FDA issued a warning letter to the OTC drug site of Dabur India Limited for data integrity violations, including a falsified equipment use log and missing laboratory records.
Published
2026-08-04
Document no.
20b61b36580f
Company / site
Dabur India Limited
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 07/24/2026
Key facts · Basis: official index plus supporting sources
Violation 1: the equipment use log presented to the investigator was found to be falsified, and OTC products distributed in the US that appeared in the original log had been deliberately left out (21 CFR 211.22(a))
Violation 2: microbiological plates recorded as incubating were not in the incubator and their disposal was unexplained, and certificate of analysis results were reported for numerous batches with no test procedure or analytical record (21 CFR 211.194(a))
Violation 3: cleaning validation for non-dedicated equipment relied on visual inspection alone, with no maximum allowable carryover limit, no quantitative residue testing and no direct surface sampling (21 CFR 211.67(b))
Action: placed on Import Alert 66-40 in June 2026, a voluntary recall carried out earlier that month, and a written response required within 15 working days
Insight · Editorial insight
FDA judged the quality unit's failure to catch the gap between raw data and reported values as a collapse of quality culture rather than a set of missing procedures. Anyone carrying an Indian site in a contract manufacturing arrangement or supply chain should check the supply impact of the import alert listing and the state of record originality verification at that site.
Check points
Issue and reconciliation control for original records such as equipment use logs, and safeguards against duplicate copies
Procedure reconciling analytical raw data against batch records and reported certificate values
Whether cleaning validation for non-dedicated equipment has quantitative residue limits and surface sampling
Violation detail · 4 items · From the source
Violation 121 CFR 211.22(a)
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).
Violation 221 CFR 211.194(a)
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Violation 321 CFR 211.67(b)
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
Violation 421 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm's quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
[Warning Letter · FDA]Thomas Brunner Hygiene GmbH — Combination not permitted by the monograph
Evidence BFDASignal High · T3CGMP
FDA issued a warning letter to Thomas Brunner Hygiene GmbH treating its syNeo antiperspirant products as unapproved new drugs and misbranded, because the active ingredient combination used is not permitted by OTC monograph M019.
Published
2026-08-04
Document no.
5f27c3276af4
Company / site
Thomas Brunner Hygiene GmbH
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 07/24/2026
Key facts · Basis: official index plus supporting sources
Finding: aluminum chlorohydrate 10% and aluminum chloride 10% were declared as active ingredients, but M019 does not permit the two to be used in combination
Determination: not generally recognised as safe and effective, so the products are new drugs under section 201(p) of the FD&C Act, and unapproved because no application is approved
Finding: the products also fail the requirements of section 505G and are therefore misbranded under section 502(ee)
Action: written response within 15 working days, with refusal of admission possible under section 801(a)(3) on import into the US
Insight · Editorial insight
This is an enforcement case where each active ingredient is in the monograph but the combination itself is not permitted, which makes the product an unapproved new drug. Firms supplying OTC products to the US should confirm that the formulation combination sits within the permitted range of the applicable monograph and that two monographs are not being stacked.
Check points
Whether the active ingredient combination in exported OTC products is within the permitted range of the applicable monograph
Whether more than one monograph is being applied at the same time, and on what basis
Record of the assessment of whether a new drug application is required
Violation detail · 4 items · From the source
Violation 121 CFR 211.165(a)
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Violation 221 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Your firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)).
Violation 321 CFR 211.84(d)(1)
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Violation 421 CFR 211.166(a)
Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
[EU GMP non-compliance · EMA]Ananta Medicare Limited — Contamination control across aseptic manufacture
Evidence AEMASignal Med · T2🧬 BiologicsGMP non-compliance
The Portuguese competent authority identified multiple critical and major deficiencies in the aseptic manufacturing areas of the Ananta Medicare Limited site in India and issued a GMP non-compliance report.
Published
2026-08-06
Document no.
186887
Site / company
Ananta Medicare Limited (India)
Issuing authority (NCA)
Portugal
Product scope
Human Medicinal Products
Original text and translation
During the inspection, multiple critical and major deficiencies were identified across the facility, particularly in areas directly associated with the aseptic manufacture of medicinal products.
Key facts · Basis: official source record kept by the collector
Non-compliant scope: aseptic preparation (dry powder injection, cephalosporins), secondary packaging, and quality control testing (sterile and non-sterile microbiology, physicochemical)
Deficiency: insufficient and reversed pressure differentials between clean areas, and sterilised material exposed to Grade B because of layout constraints
Deficiency: gowning, aseptic technique and barrier system handling not followed, rusted pass boxes and contaminated balances and step stools, and open containers used within Grade B
Deficiency: data integrity defects including missing records and reporting of analyses that were not performed, and a contamination control strategy introduced late and not covering the risks
Insight · Editorial insight
European inspection of a sterile site is converging on a single axis, the effectiveness of the contamination control strategy, rather than on a list of individual deficiencies. Firms running aseptic lines or using an Indian aseptic contract site should check the measured history of the pressure cascade between clean areas, the control of materials inside Grade B, and the state of the contamination control strategy.
Check points
Measured pressure cascade values between clean areas and the history of any reversals
Control of open containers and unapproved materials entering Grade B
Coverage of risk items in the contamination control strategy and its revision cycle
Non-compliance detail · From the source · EudraGMDP
Issuing NCA · PortugalHuman Medicinal Products
Non-compliant operations
Original · EudraGMDP
1NON-COMPLIANT MANUFACTURING OPERATIONS
1.1Sterile products
1.1.1Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6Other: Dry powder Injection(en) Special Requirements:
7Other: Cephalosporins(en)
1.5Packaging
1.5.2Secondary packaging
1.6Quality control testing
1.6.1Microbiological: sterility
1.6.2Microbiological: non-sterility
1.6.3Chemical/Physical
Nature of non-compliance
Original · EudraGMDP
During the inspection, multiple critical and major deficiencies were identified across the facility, particularly in areas directly associated with the aseptic manufacture of medicinal products. The nature and extent of these deficiencies demonstrate systemic weaknesses in contamination control, aseptic behaviour, equipment integrity, data governance, and quality control practices, which collectively pose a significant risk to the sterility, safety and overall quality of the products manufactured in Block A. Critical failures were observed in facility design and pressure cascade maintenance, including inadequate differential pressures between classified and non classified areas, reversed pressure gradients, and layout constraints that resulted in sterile API being exposed in Grade B. These issues undermine the fundamental environmental controls required for aseptic processing. Serious concerns were also identified regarding personnel behaviour and aseptic practices, with operators failing to comply with gowning requirements, aseptic discipline, RABS handling procedures, and environmental protection measures. Such behaviours directly compromise sterility assurance and indicate insufficient training and oversight. The inspection further revealed equipment in poor condition, including rusted pass box, unclean balance and step ladder, and the use of open containers for rejected materials and IPC samples within Grade B. These deficiencies represent unacceptable contamination risks within critical manufacturing areas. Significant weaknesses were found in the organisation and control of materials and GMP documentation, including the presence of operational documents, microbiology records, Petri dishes, and other materials stored in uncontrolled areas such as the expansion zone. The discovery of a deteriorated and unidentified gas cylinder connected to a pipeline used for aseptic filling further heightened concerns regarding uncontrolled substances potentially coming into contact with the product. Critical data integrity failures were identified, including missing records, inconsistent entries, unclear terminology, and analytical activities reported but not performed. These issues undermine the reliability of GMP documentation and raise concerns regarding the accuracy of batch release decisions. In the Quality Control laboratories, essential tests for APIs were not performed by the manufacturer, retention samples were improperly stored, finished product samples lacked proper identification, and sterility testing was conducted using unsuitable equipment. These deficiencies critically affect the validity of analytical results and the assurance of product quality. Major gaps were also identified in the Contamination Control Strategy (CCS), which was implemented late and failed to address several contamination risks, including API exposure in Grade B, environmental monitoring vulnerabilities, personnel limits, HEPA filter replacement rationale, and disinfectant approval. Finally, batch documentation lacked evidence of required sampling and incomplete line clearance verification, compromising batch traceability and readiness for aseptic operations.
Action taken/proposed
Original · EudraGMDP
Others The Portuguese market is not impacted, as no medicinal products have been placed on the market by the manufacturer concerned, and alternative manufacturers with medicinal products containing the same active substance and strength are authorised in Portugal. It was decided that, for the manufacturer concerned, a Non-Compliance Report (NCR) was issued until all critical and major deficiencies have been adequately addressed and their implementation confirmed through a follow-up inspection.
[FDA 483 observation · FDA]Emcure Pharmaceuticals Limited — Aseptic line control and complaint handling
Evidence BFDASignal High · T3483
FDA inspected the Emcure Pharmaceuticals Limited site and issued seven observations, covering equipment performance qualification that was never carried out, uninvestigated complaints about stoppers, and residue in the ISO 5 area.
Published
2026-08-05
Document no.
fda483-194060
Site / company
Emcure Pharmaceuticals Limited · FEI 301459503
Site · type
Manufacturer · 483
Inspection date
05/15/2026
Key facts · Basis: official index plus supporting sources
Observation 1: requalification of the vial filling and stoppering machine (ES/MFG/366) did not evaluate or qualify worst-case speed, and around 225 complaints about stopper dislodgement were received over the last four years
Observations 2 and 3: complaints that identified no batch number were closed without investigation, and complaints of lack of effect were tested for assay only
Observations 5 and 6: the airflow visualisation study performed in 2023 simulated interventions without removing exposed vials and stoppers, and residue and evidence of gap filling were found on surfaces in the ISO 5 area
Observation 7: audit trails were permitted to be reviewed on paper printouts, and analysts held rights that let them see results before deciding whether to save a chromatogram
Insight · Editorial insight
FDA took issue with complaints of the same type accumulating over four years without the investigation widening to other batches, which puts the effectiveness of complaint handling at the entrance to any assessment of an aseptic line. Firms running injectable lines should confirm how far investigation extends for complaints with no batch number, and how trend analysis is applied to complaints about stoppers and container closure.
Check points
Scope of investigation and closure requirements for complaints that carry no batch number
Trigger for extending an investigation to other batches once complaints of the same type accumulate
Whether intervention simulation in airflow visualisation includes removal of exposed containers and stoppers
Observation detail · 6 observations · From the source
Inspectors: Brandy N Lepage · Jessica S Estriplet
Observation 1
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, A) Complaints that identify a product but not a specific batch are not fully investigated. According to the procedure titled “Handling of Market Compliant” CQ-039/09, section 5.2.4.3, the investigation ofproduct complaints that include the product name but are missing information (i.e., batch number, complaint sample) must include assessment of drug product quality defects that include or is not limited to, drug product deviation history, stability data, retain samples, visual inspection records, annual product reviews, and relevant OOS/OOT investigations. The following drug product failure to meet specifications complaint investigations were listed as “non-compliant” and closed without a full investigation to determine potential root cause and corrective and preventative actions: Summary 127661 mL vials, potency lost over due to no lot number ime.” PR. No 08/11/2023 ww having to give |No investigation was performed; closed brand@@ than
Observation 3
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
Specifically, the procedure titled “Handling of Market Complaint” CQ-039 indicates that investigations must include the evaluation of sterile drug product’s possible failure to meet its specifications. The following customer complaints were reported for lack of effect: however, the control samples were not tested for multiple release and stability testing metrics (1.e.. oe
Observation 4
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Specifically, your firm failed to implement and maintain controls to prevent potential contamination of the drug products produced on the Blocka) Line @@ On 05/08/2026, multiple locations within the ISO 5 gw a)
Observation 7
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Specifically, A) The procedure titled “Audit Trail Review” SOP/QAD/032-07 permits Quality Assurance does not require Quality Assurance to review audit trails electronically. Per sectiongyg@ an audit trail review is permitted via paper-based documentation (i.e., “hard copy” and “PDF file format.)” Quality Assurance is responsible for performing periodic audit trail reviews ofCGMP software a@ and prior to batch release. B) According to the document titled “Configuration Specification for Computerized System” EM/CS/07/CS/009/21, Sr.No 49, an analyst has permission to “view quantitation peak fields in review.” The setting grants an analyst the ability to see area counts and results of a chromatography-based test prior to deciding whether to save the processed chromatogram or enter additional integration parameters. *DATES OF INSPECTION 5/06/2026(Wed), 5/07/2026(Thu), 5/08/2026(Fr1), 5/11/2026(Mon), 5/12/2026(Tue), 5/13/2026(Wed), 5/14/2026(Thu), 5/15/2026(Fri)
FDA inspected the sterile site of Zydus Lifesciences Limited and issued seven observations, covering inadequate verification of airflow on the filling line, residue and cracks on ISO 5 barrier surfaces, and poor condition of the Grade B cleanroom.
Published
2026-08-05
Document no.
fda483-194061
Site / company
Zydus Lifesciences Limited · FEI 3012977526
Site · type
Sterile Manufacturer · 483
Inspection date
05/05/2026
Key facts · Basis: official index plus supporting sources
Observation 1: the distance from the HEPA filters to the work surface in the critical aseptic filling area was not defined during qualification, and the change in air velocity at working height between the earlier performance qualification in 2018 and requalification in 2025 was not investigated
Observations 2 and 3: residue and evidence of gap filling on ISO 5 barrier surfaces, cracks near the HEPA filters, and a Grade B cleanroom floor that was worn and delaminating
Observation 4: descriptions of Grade B surface sampling locations were insufficient, sampling history for ancillary equipment was not traceable, and the procedure defined non-viable particle excursions during interventions as not being deviations
Observations 6 and 7: turbulence was seen in airflow visualisation and neutral buoyancy of the smoke was not demonstrated, and SCADA and environmental monitoring electronic data were reviewed only as printouts before batches were released
Insight · Editorial insight
FDA is now examining the adequacy of the airflow visualisation protocol itself, down to demonstrating neutral buoyancy and having pre-approved acceptance criteria. Sterile sites should confirm that smoke study reports carry pre-approved acceptance criteria and that review of printouts is not standing in for review of electronic raw data.
Check points
Whether the airflow visualisation study has a pre-approved protocol and acceptance criteria
Evidence demonstrating neutral buoyancy of the smoke and the density specification
Whether SCADA and environmental monitoring electronic data are reviewed electronically before release
Observation detail · 7 observations · From the source
Inspectors: Jessica S Estriplet · Brandy N Lepage
Observation 1
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Specifically, the distance proximal to the work surface for HEPA filters in the critical area that aseptic filling transpires on the m@ Filing Line (Equipment ID # m@ was not defined during equipment qualification studies. Additionally, there were large changes in the working height air velocities from the imitial study “Performance Qualification Report for @@ Line LAFs” PQR®@® /01, dated: 04/26/2018 and the requalification study “Air Flow Visualization Study (Smoke Test) Report for m@ Filling Line-March 2025 & April-2025” REP-25-044- 01, dated: 11/07/2025, which were not investigated, nor did your firm perform a risk assessment on the potential impact to drug product quality. Finally, the firm does not address air velocity working height specifications and/or requirements in the contamination control strategy “Contamination Control Strategy (CCS)” REP-25-054-00.
Observation 2
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Specifically, your firm failed to implement and maintain controls to ensure the sterility of drug products
Observation 3
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable.
Specifically, the facility cleanroom #@@ that is a Grade B background to them@ = RABs which contains the m@ Filing Line (Equipment ID # @@ is not in a good state of repair, in that, the m@ within the Grade B controlled classified cleanroom were grossly stained and o® Additionally, the m@ floors within the Grade B cleanroom were visibly worn, peeling, and flaking in numerous locations which could hinder effective cleaning of the surfaces. The m@ Filing Line (Equipment ID # 0) is utilized to produce m@ Injection, »@ mg/mL).
Observation 4
In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process.
Observation 5
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
Observation 7
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Specifically, your firm does not have procedures in place for electronic data review prior to batch release. The procedure titled “Review of Electronic Audit Trails” 0310-SOP-QA-00075, section 6.11.6, indicates that QA is permitted to perform batch release using print-outs of batch generated information from critical process equipment such the SCADA for o@ Filling Line (Equipment ID # 0) , which governs the operation of the m@ Machine (Equipment ID #@@ , 0) (Equipment ID # ww , and the wm@ Filling and Stoppering Machine (Equipment ID #@@ . For example, the “Checklist to Ensure Completion of Data Audit Trail Review” 0310-SOP-QA-00075-10, for m@ Injection ®® mg®@mL, lot OTC) the SCADA for m@ Filling Line raw data review was performed by “print out” by QA on 05/10/2024. Additionally, total air particulate environmental monitoring electronic data for Grade A- Grade D controlled classified areas, is not reviewed by Quality Assurance prior to batch release, only hard copies of the data are assessed. *DATES OF INSPECTION 4/27/2026(Mon), 4/28/2026(Tue), 4/29/2026(Wed), 4/30/2026(Thu), 5/01/2026(Fri), 5/04/2026(Mon), 5/05/2026(Tue)
[FDA 483 observation · FDA]MSN Life Sciences Private Limited, Unit II — Weak OOS investigation, no OOT limits
Evidence BFDASignal High · T3483
FDA inspected the active ingredient site of MSN Life Sciences Private Limited, Unit II and issued four observations, covering weak justification for invalidating out-of-specification results and laboratory incidents that were never opened.
Published
2026-08-05
Document no.
fda483-194064
Site / company
MSN Life Sciences Private Limited, Unit II · FEI 3011543392
Site · type
Active Pharmaceutical Ingredient Manufacturer · 483
Inspection date
09/13/2024
Key facts · Basis: official index plus supporting sources
Observation 1: on retest of OOS-23064 the analyst used a different sample solution without that being investigated as a separate deviation, and the system suitability failure in OOS-24006 was not investigated as a laboratory incident, with incident forms also missing for OOS-24032 and OOS-23093
Observation 2: out-of-specification results, deviations and system suitability failures were bundled into a single quality event investigation, diluting individual counting and trend analysis
Observation 3: out-of-trend ranges were not calculated or evaluated for products with few batches or not reflected in the laboratory information system (SOP CQC-0003-002)
Observation 4: no hot water was supplied to the hand washing area before entry to the production clean area
Insight · Editorial insight
FDA is looking less at whether invalidating an out-of-specification result was justified than at whether the secondary events arising during that investigation, the retest error and the system suitability failure, were handled as separate events. Quality control organisations should confirm the criteria for opening a separate deviation for a laboratory error found during an out-of-specification investigation, and the rule for calculating out-of-trend limits for products with few batches.
Check points
Criteria for opening analytical errors and system suitability failures found during an OOS investigation as separate events
The unit of counting for quality events and the risk of omissions in trend analysis
Method for setting out-of-trend limits for products with an insufficient number of batches
Observation detail · 4 observations · From the source
Observation 1
Your firm failed to thoroughly investigate critical deviations and/or the failure(s) of a batch to meet specifications.
Your quality unit failed to review all critical deviations or non-conformances and related investigations for all API products.
Specifically, There were quality-related events (OOS, deviations, system suitability failures [invalid and incident]) that were not separately identified for the purposes of review and/or trending purposes to identify quality-related deficiencies. Multiple quality-related events were identified within one (1) quality event investigation which can dilute the total number of quality-related events to review within a given time period.
Observation 3
Your quality unit failed to perform one of it's core responsibilities to ensure that critical deviations are investigated and resolved.
Specifically, Out-of-Trend (OOT) ranges were not calculated and evaluated for a number of specification tests for some of your API products that were: 1) manufactured with less thanw® batches and 2) were not updated within the firm's recently implemented LIMS system. According to your firm's SOP CQC-0003-002 titled "HANDLING OUT-OF-TREND RESULTS" with an effective date of 05/06/2023 (June 5th 2023), section®@ describes a way for handling OOT during API release testing for APIs without trend limits calculated from the m@batches. FACILITIES AND EQUIPMENT SYSTEM
Observation 4
Your production areas fail to provide adequate washing facilities for personnel.
Specifically, The washing area(s) prior to entry into the cleanroom area(s) of production did not have access to hot water for hand washing.
[FDA 483 observation · FDA]SNJ Labs Private Ltd. — OOS invalidation and standalone instrument data
Evidence BFDASignal High · T3483
FDA inspected the active ingredient site of SNJ Labs Private Ltd. and issued six observations, covering repeated invalidation of out-of-specification results, absence of data control on standalone analytical instruments, and poor cleanroom hygiene.
Published
2026-08-05
Document no.
fda483-194065
Site / company
SNJ Labs Private Ltd. · FEI 3026587575
Site · type
Active Pharmaceutical Ingredient Manufacturer · 483
Inspection date
02/06/2026
Key facts · Basis: official index plus supporting sources
Observation 1: four out-of-specification assay results on finished active ingredient between April and September 2024 were invalidated by retesting, although the instrument concerned had had no preventive maintenance since 2020, and batches were analysed and released during that period without a risk assessment
Observation 2: the test method used to set the retest period was not stability indicating and could not detect degradation products
Observation 3: data from the atomic absorption, UV/VIS and voltammetry instruments was backed up to an external drive, analysts held rights to delete and rename files and to change the date and time, and the spreadsheets used for calculation were not validated
Observations 4 and 6: contamination and cracks were found in cleanroom ceilings and floors, media were used without growth promotion testing, and original inoculation counts were not recorded
Insight · Editorial insight
At active ingredient sites, standalone analytical instruments not connected to a server are being identified as the weak point for data integrity. Quality control laboratories should confirm the file permissions and clock change rights on standalone instruments and the validation status of the spreadsheets used for calculations.
Check points
Data storage and backup permissions on standalone instruments not connected to a server
Whether analyst accounts are blocked from changing the system date and time
Whether the method underpinning the retest period is stability indicating, and the forced degradation data behind it
Observation detail · 5 observations · From the source
Inspectors: Paranthaman Senthamarai Kannan
Observation 2
Your firm failed to use validated and stability-indicating test procedures.
Your firm failed to use validated, stability-indicating methods to test active pharmaceutical ingredients (AP) w@ eo) intended for the US market when assigning retest dates of@ The analytical method used for
Observation 3
Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of data.
a. The finished product testing data fora@ intended for the US market using stand-alone instruments, atomic absorption spectrophotometer AAS (SNJ/QC/AAS/37), UV/VIS Spectrophotomer (SNJ/QC/UV/39), and voltamwter (SNJ/QC/VM/15) in the computer “Cu BY dhive were backed up tom@ external hard driveso@ »@ according to your IT administrator, Analysts have unrestricted privileges to cut, copy, paste, delete and rename data files on computer hard drives and there is no assurance that data are original/unaltered before backup. Your firm has the capability to save [ILC data on the server, however, your firm has not conducted gap assessments for GMP data files saved on computers connected to stand alone instruments. b. Your firm’s analysts have privileges ofchanging date and time settings on computers attached to the atomic absorption spectrophotometer and UV-Vis spectrophotometer. c. Your firm failed to validate the Excel software used for laboratory data calculations. Your QC Manager confirmed this on February 4, 2026. The results calculated for m@ assay for M@ finished product batch a @ using Excel software were not available during the inspection and your QC manager stated that your firm’
Observation 4
Failure to properly maintain buildings and facilities used in the manufacture of API.
Your firm failed to maintain facility and equipment in clean status for manufacturing and processing of®@® (b) (4) (Plante and om API (Plant ®) (4
Observation 5
Failure to have adequate written procedures for the sampling of raw materials.
Your firm has inadequately written SOPs for raw material sample collection and in-process control samples that fail to provide sufficient instructions for QC personnel and operators. SOP QCG/006-05 (Sampling of Raw materials and packing materials) lacks detailed information on how to collect samples from raw material bags. SOP PDG/032-02 (SOP for sampling procedure of in-process and intermediate sample) does not provide adequate details for collecting in-process samples form@
Observation 6
Failure to follow and document laboratory controls at the time of performance and failure to document and explain any departures from laboratory procedures.
[FDA 483 observation · FDA]Sentiss Pharma Pvt. Ltd. — Media fill and environmental monitoring gaps
Evidence BFDASignal High · T3483
FDA inspected the sterile site of Sentiss Pharma Pvt. Ltd. and issued ten observations, covering media fill design defects, the absence of acceptance criteria for aseptic operator qualification, and inconsistencies in microbiological test records.
Published
2026-08-05
Document no.
fda483-194066
Site / company
Sentiss Pharma Pvt. Ltd. · FEI 3008250236
Site · type
Sterile Manufacturer · 483
Inspection date
05/23/2017
Key facts · Basis: official index plus supporting sources
Observation 2: the line ran with no containers present for most of the media fill duration, interventions during line stoppages were performed with no containers on the conveyor, and acceptance criteria for aseptic operator qualification were not defined
Observation 2C: operators in the Grade A area during filling were judged against Grade B limits, and although the whole body enters Grade A during set-up only the hand plates were held to the Grade A criterion
Observation 3: incubation conditions for environmental and personnel monitoring media were not validated for recovery of bacteria, yeast and mould - a repeat observation
Observation 10: the number of environmental and personnel monitoring plates read was not reconciled against the numbers sterilised and discarded - a repeat observation - and the endotoxin test did not include a control standard endotoxin series
Insight · Editorial insight
FDA is carrying as a repeat observation the point that where a media fill does not simulate real production conditions, the basis for sterility assurance does not stand at all. Firms running aseptic lines should confirm the number of containers actually filled during a media fill, the conditions under which interventions are performed, and the criteria applied to personnel monitoring in Grade A.
Check points
Number of containers actually filled in the media fill and how closely it simulates production conditions
Acceptance criteria for Grade A operator monitoring and how far they apply during set-up
Reconciliation records between plates read and plates discarded for environmental and personnel monitoring
Observation detail · 9 observations · From the source
Inspectors: Sandra A Hughes · Eileen A Liu
Observation 1
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
A. Review of data integrity issues from 2014 FDA inspection resulted in the following discrepancies: The investigation into the inaccuracies in data records and reporting did not include an assessment into the extent of the data integrity deficiencies or a detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data generated in support of submitted filings or a comprehensive description of the root cause ofyour data integrity lapses. The investigation did not include interviews with microbial or cleaning personnel nor were production videos reviewed from other batches to determine how wide spread the data integrity issues were. In addition, the recording function of the production cameras was eliminated without adequate justification. B. During receiving, sterileg@ failed sterility on 17 FEB 2015. The resulting investigation determined the firm would increase the sampling for sterility from@® 0 @@ and to find a new suppler. During the inspection it was confirmed the firm still only testsgq Of@@ _ for sterility and are still using the same supplier. C. w@ can be aya up tom@times per procedure N/PR/224/03. Since January 201
Observation 2
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
A. Validation of the @@ RABS) aseptic fill line: Media fills: 1. For filling duration, media fill@@ lists the fill time as M@ During the review of the video tape of@ it was noted that vials were not present on the line for the majority of the time the line was running. For example.@ specifies filling was performed at oO@ on 01 April 2017. Although approximately @«@ bottles should have been filled during this duration, onlyg@ bottles were documented as being filled. Management stated the firm focused on having the filling machine running without bottles on
Observation 3
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
A. The@@ temperature incubation ofo@ media plates are not validated to demonstrate optimal recovery of a wide range of microorganisms including bacteria, yeast, and mold species. The m@ plates are used in the viable environmental monitoring (EM) and personnel monitoring (PM) of ISO classified areas. After sampling, media plates are incubated o@ @ 4) The firm has no data to show they@ incubation at m@ @ °C is able to support the growth of normal skin flora microorganisms that thrive at body temperature (37°C). Similarly, the firm lacks assurance that the m@ incubation at @) 4) °C will not suppress the recovery of yeast and mold species that otherwise thrive at ambient temperature. B. Section@@ of the SOP N/QC/067/23, entitled, “Sampling and Testing ofm@ 0) Samples” specifies that@@ samples for microbiological analysis shall be tested withing of the collection. Review of source data revealed microbiological analysis of@ _ is not always conducted within the specified time frame. This is a repeat observation.
Observation 4
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials and drug products conform to appropriate sta...
ndards of identity, strength, quality and purity.
Observation 5
The quality control unit lacks the responsibility and authority to approve and reject all components.
SOP SPL-QA-SOP-062-00, entitled, “Vendor Qualification ofGMP Consumables” was not followed. A. Theww supplier@@ has not been qualified @@ currently in use on the m@ filling line to make sterile m@ drug products were not inspected or approved by Quality. B. The firm failed to qualify supplies@ for critical GMP consumables. Specifically, the firm failed to qualifym@ form@ media such as@m@
Observation 6
Changes to written procedures are not reviewed and approved by the quality control unit.
The written stability program for drug products does not include reliable, meaningful and specific test methods.
The firm does not take into account mass balance when performing stressstudies. During the review of the stress studies performed during the validation of analytical methods, not all peaks were integrated. In one case, approximately 50% of a main peak was missing during one study without generating any impurities. No investigation was initiated and the report states the forced degradation results meet the acceptance criteria.
Observation 9
Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
Observation 10
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
A. Numbers of EM, PM, and Micro Lab media plates read, discarded, and destroyed cannot be reconciled. For example, 1. On 05/15/2017, a total of@ media plates were read and released for disposal. Sterilization and Disposal Record of Microbiological Waste (form N/QC/071/01/04) showeda total of@ plates were m@ discarded.
[FDA 483 observation · FDA]C.A.T. Gmbh and Co. KG — System suitability not established
Evidence BFDASignal High · T3483
FDA inspected the contract testing laboratory C.A.T. Gmbh and Co. KG and issued one observation, that system suitability was not established for chromatographic testing.
Published
2026-08-05
Document no.
fda483-194067
Site / company
C.A.T. Gmbh and Co. KG · FEI 3004422881
Site · type
Contract Testing Laboratory · 483
Inspection date
03/20/2012
Key facts · Basis: official index plus supporting sources
Observation 1: system suitability was not established by replicate injections of the standard solution for residual solvent and optical purity testing of numerous active ingredient lots
Practice: according to the representative, system suitability was performed with a single injection of the standard solution
Finding: standard solution was not injected during the analysis and after the final sample injection, so the validity of the system at the end of the run was not confirmed (based on USP <621>)
Insight · Editorial insight
This confirms that the USP <621> system suitability requirement applies in full to chromatographic data generated by a contract testing laboratory. Firms that outsource testing should make the number of system suitability injections and the rule for reconfirmation during a run explicit items in the contract and the audit.
Check points
The contract laboratory's rule on replicate standard injections for system suitability
Procedure for reconfirming system suitability during and after the analytical run
Observation detail · 1 observation · From the source
Observation 1
The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Specifically, USP <621> Chromatography states that system suitability tests are an integral part of gas and liquid chromatographic methods which verify that the system is adequate for the intended analysis. It states that replicate injections of standard solutions are compared to ascertain whether precision requirements are met. Additionally, it states that system suitability ascertains final operating system effectiveness, and that additional injections of standard solutions are required at appropriate times to demonstrate system suitability throughout the chromatography run. Using chromatographic methods, your firm analyzed residual solvents and/or the optical purity ofg) on of multiple lots of the Active Pharmaceutical Ingredient (API) for the drug product gy¢y including lots gy However, your firm did not establish system suitability through multiple consecutive injections of the appropriate standard solutions. According to the CEO and Owner, your firm currently performs system suitability by analyzing g)@ injection of the appropriate standard solutions g Additionally, your firm did not confirm the effectiveness of the final operating system through injecting standard solutions
[FDA 483 observation · FDA]Baxalta US Inc. — Cross-contamination assessment and CAPA gaps
Evidence BFDASignal High · T3483
FDA inspected the Baxalta US Inc. site and issued five observations, covering repeated recoveries in the Flexbumin manufacturing area that were never investigated and an inadequate cross-contamination assessment.
Published
2026-08-04
Document no.
fda483-194052
Site / company
Baxalta US Inc. · FEI 3012385969
Site · type
Manufacturer · 483
Inspection date
11/26/2025
Key facts · Basis: official index plus supporting sources
Observation 1: there were numerous false positive recoveries from samples taken in the Flexbumin manufacturing area since 31 October 2022, and no impact assessment was made because the confirmatory result was treated as a recorded test
Observation 1: false positive recoveries between 15 September 2022 and 27 October 2025 were not investigated and no impact assessment was made, while numerous Flexbumin lots were manufactured in that period
Observation 2: CAPA No.4909673 on foreign matter in a lot manufactured on 21 November 2023 passed its target closure date and remained open until 4 November 2025, and the same type recurred, opening CAPA No.5165429
Observations 3 to 5: there is no validated method to test Flexbumin for cross-contamination, foreign matter found at final visual inspection was not recorded at the time it occurred, and maintenance on the supply system used for cleaning was not documented or evaluated
Insight · Editorial insight
FDA is treating the practice of closing an environmental recovery as a false positive on a single confirmatory test as avoidance of investigation. Biologics sites should confirm the basis on which a recovery is invalidated, the impact assessment records for lots manufactured during that period, and how overdue CAPA closures are managed.
Check points
Basis for declaring an environmental recovery a false positive and the detection range of the confirmatory method
Impact assessment records for lots manufactured during the period of false positive determinations
Management of CAPAs past their target closure date and whether effectiveness checks are carried out
Observation detail · 5 observations · From the source
Inspectors: Peng Zhou · Shafig Ahadi
Observation 1
The responsibilities and procedures applicable to the quality control unit are not fully followed.
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Observation 3
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Specifically, A. Flexbumin manufactured at your facility has not been tested for potential (b) (4) cross- contamination. You do not have a validated method to test for (1B) (4) __ in Flexbumin drug product; approximately (5) (4) jots have been manufactured between September 15, 2022 and October 27, 2025, of which ) @) lots were for the US market. B. Surface (b) (4) recovery samples are subject to the current preliminary method by (6) (4) Protocol PD-97-0420-B “Analytical Validation of Procedures for the Detection of (b) (4) in Environmental Samples” and if a positive result is obtained, testing is then performed with a confirmatory test method, Procedure RD-02-01-020 “ (b) (4) Limit Test as a Referee Method for Medical Products”,. Neither can detect (b) (4) C. You have not performed a risk assessment to evaluate the impact of sterility testing performed in a (b) (4) building.
Observation 4
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
[Guidance · FDA]Radiology Devices; Reclassification of Digital Breast Tomosy… — Breast imaging device reclassification proposed
Evidence AFDASignal Med · T2Guidance
FDA proposed reclassifying digital breast tomosynthesis (DBT) systems (product code OTE) from class III to class II, making them subject to premarket notification.
Published
2026-08-10
Document no.
2026-16209
Issuing authority
FDA
Topic
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Original text and translation
The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject…
Key facts · Basis: official source record kept by the collector
Scope: digital breast tomosynthesis (DBT) systems, product code OTE
Change: reclassification from class III (premarket approval) to class II (special controls), subject to premarket notification
Applicability: a change to medical device classification regulations, not directly applicable to drug GMP requirements
Insight · Editorial insight
It continues FDA's approach of reclassifying class III devices down to special controls on the basis of accumulated marketing experience. Because the subject is device classification, there is no direct effect on drug manufacturing and quality work, and it needs attention only where a device business is run alongside.
Check points
Whether the product code is handled, if a device business unit exists
Timing of the move to premarket notification if the reclassification is finalised
[Administrative action · MFDS]한미약품(주) — Warning over late protocol amendment report
Evidence AMFDSSignal High · T3Administrative action
The Ministry of Food and Drug Safety issued a warning, recorded as a first offence, for a late report of a clinical trial protocol amendment and for breaches of quality assurance for the trial and quality control of trial data.
Published
2026-08-10
Document no.
admin-2026005676
Companies
한미약품(주)
Action
경고, 1차
Shown in the original Korean: 1 value in this table.
Original text
① 임상시험계획 변경 보고 지연
② 임상시험의 품질보증 및 임상시험자료의 품질관리 위반
Key facts · Basis: official source record kept by the collector
Violation: late report of an amendment to the clinical trial protocol
Violation: breach of quality assurance for the clinical trial and of quality control of clinical trial data
Action: warning, first offence, final action dated 10 August 2026
Applied: Pharmaceutical Affairs Act article 34(1) and the Korean Good Clinical Practice standard in Annex 4 to the Rules on the Safety of Drugs
Insight · Editorial insight
In the clinical trial domain too, quality control of data is being carried into enforcement as a violation separate from a procedural delay. Firms running clinical trials should confirm the system that tracks reporting deadlines when an amendment arises and the records of quality assurance checks on trial data.
Check points
System tracking the reporting deadline once a protocol amendment arises
Records of clinical trial quality assurance activity and data quality control
[Administrative action · MFDS](주)바른한방제약 — Manufacture suspended over ash specification
Evidence AMFDSSignal High · T3Administrative action
The Ministry of Food and Drug Safety suspended manufacture of a herbal product for three months because it failed the specifications for ash and acid-insoluble ash.
Shown in the original Korean: 1 value in this table.
Original text
○ 품질부적합: 회분, 산불용성회분
Key facts · Basis: official source record kept by the collector
Grounds: quality failure - ash and acid-insoluble ash
Action: three-month suspension of manufacture of the affected product (19 August 2026 to 18 November 2026)
Applied: Pharmaceutical Affairs Act article 62(11) and article 76, and Rules on the Safety of Drugs article 95, Annex 8
Final action date: 5 August 2026
Insight · Editorial insight
Ash and acid-insoluble ash are generally indicators that can be linked to the level of inorganic matter and soil carried in with a crude drug material, and this action shows a failure on those attributes leading directly to suspension of manufacture for the product. Firms using crude drugs as materials should confirm the controls on pre-treatment such as washing and sorting, and the release testing history against the ash specification.
Check points
Control criteria for pre-treatment of crude drug materials, including washing and sorting
Release testing history against the ash and acid-insoluble ash specifications
[Guidance · MFDS]바이오의약품 사전 GMP 평가 지침 — Guidance on pre-approval GMP for biologics
Evidence BMFDSSignal Med · T2Guidance
The Ministry of Food and Drug Safety published guidance on pre-approval GMP assessment for biological products.
Published
2026-08-04
Document no.
data0010-15270
Issuing authority
MFDS
Topic
바이오의약품 사전 GMP 평가 지침
Shown in the original Korean: 1 value in this table.
Key facts · Basis: official index plus supporting sources
Subject: guidance on pre-approval GMP assessment for biological products
Issued: MFDS, 4 August 2026
Detail: the full text was not obtained, so the original document needs to be consulted
Insight · Editorial insight
Setting out the criteria for pre-approval GMP assessment at the licensing stage for biological products as guidance can affect how submission dossiers are prepared in practice. Firms preparing a biological product application should read the guidance for the scope of the documents required and the assessment procedure.
Check points
Scope of documents required for pre-approval GMP assessment of biological products
Effective date in the guidance and how it differs from the existing procedure
Inspection date 22 May 2026, published 3 August 2026
Insight · Editorial insight
A post-approval inspection of a single finished product site closing without deficiencies shows the post-approval inspection cycle turning normally. Sites with a post-approval inspection ahead of them are worth checking for whether change control since the previous inspection is in order.
Check points
State of the record of change controls raised since the previous inspection
Whether the scope covered by the post-approval inspection matches the site's own manufacturing scope
Evidence AMFDSSignal Med · T2💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety carried out a post-approval GMP inspection of a herbal medicine production centre on 7 May 2026 and assessed it as having no deficiencies.
Published
2026-08-03
Document no.
gmpinspect-1P-6WXvKgB4
Site
한국한의약진흥원 한약제제생산센터
Inspection period
2026-05-07~2026-05-07
Original text
평가 결과 지적(보완)사항(Deficiencies) 없음 의 료 제 품 안 전 과
Key facts · Basis: official source record kept by the collector
Outcome: no deficiencies on assessment
Subject: a herbal medicine preparation production centre, post-approval, finished product (single)
Inspection date 7 May 2026, published 3 August 2026
Insight · Editorial insight
Facilities producing herbal preparations are assessed under the same post-approval GMP inspection framework as finished product sites. Firms that have herbal preparations made under contract, or buy them in, can use the inspection category and outcome for that facility as supplier assessment evidence.
Check points
Category and outcome of the most recent GMP inspection at contract producers of herbal preparations
Whether the inspection outcome is reflected in supplier assessment records
[GMP inspection · MFDS](주)팩슨 — About two months from inspection to publication
Evidence AMFDSSignal Med · T2GMP inspection
The Ministry of Food and Drug Safety carried out a post-approval GMP inspection on 29 May 2026 and assessed the site as having no deficiencies, with the result published on 3 August 2026.
Published
2026-08-03
Document no.
gmpinspect-1P-6YUq0LLc
Site
(주)팩슨
Inspection period
2026-05-29~2026-05-29
Original text
평가 결과 지적(보완)사항(Deficiencies) 없음 의 료 제 품 안 전 과
Key facts · Basis: official source record kept by the collector
Inspection date 29 May 2026, published 3 August 2026 - roughly two months between inspection and publication
Insight · Editorial insight
With around two months between the inspection and publication of the result, published information alone is a poor basis for judging a supplier's current state. Where GMP inspection disclosures are used in supplier assessment, it is safer to judge currency by the inspection date.
Check points
Which date supplier assessment treats as authoritative, the inspection date or the publication date
Direct audit or enquiry procedures that compensate for the publication lag
A voluntary recall was started for a dental local anaesthetic injection because part of the package insert, the precautions for use, was missing.
Published
2026-08-06
Document no.
recall-28c806a97fb4
Companies
신원덴탈(주)
Product
셉타네스트주1/100,000
Original text
첨부문서 누락(사용상의 주의사항 일부)에 따른 영업자 회수
Key facts · Basis: official source record kept by the collector
Reason: part of the package insert (precautions for use) was missing
Type: voluntary recall, not mandated, recall order dated 6 August 2026
Product: a dental injection presented as 1/100,000 (product standard code 200308019)
Insight · Editorial insight
Here the ground for recall is a missing element of the package insert rather than any test result on the product itself. Firms should confirm that the step verifying the presence and version of the package insert in the packaging process actually operates.
Check points
The step in packaging that confirms insertion of the package insert and verifies its version
Reconciliation of printed material against the revision history when precautions for use change
[Recall (Health Canada) · Health Canada]JAMP Pharma — Tablets larger than specification
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada published recall information for JAMP Methotrexate 10 mg Tablets from JAMP Pharma on product quality grounds, because some lots may contain tablets larger than specification.
Published
2026-08-05
Document no.
hc-82429
Companies
JAMP Pharma
Product
JAMP Methotrexate 10 mg Tablets
Class
Type II
Original text and translation
Product quality
Key facts · Basis: official source record kept by the collector
Reason: product quality - the affected lots may contain tablets that exceed the specified size
Class: Type II
Product: JAMP Methotrexate 10 mg Tablets, from JAMP Pharma
Advice: verify whether product on hand is affected and consult a healthcare provider before discontinuing use or for any health concerns
Insight · Editorial insight
Variation in tablet size can generally be linked to weight and thickness control in compression, and for a dose-sensitive product such as methotrexate that variation leads straight to a recall. Firms running tablet lines should confirm the in-process weight and thickness control limits and the criteria for sorting out oversized tablets at final inspection.
Check points
In-process control limits for weight and thickness in compression and the action taken on an excursion
Criteria for sorting out tablets of abnormal size at final visual inspection
Recall detail · From the source · Health Canada
Active ingredient · 10 mgDosage form · Tablet
What you should do
Original · Health Canada
Verify whether your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product, or if you have any health concerns.Contact the recalling firm if you have any questions about the recall.Report any health product related side effects to Health Canada.Report any other health product safety complaints to Health Canada.
Evidence AFDASignal Med · T2💊 Small moleculeRecall
Major Pharmaceuticals recalled levothyroxine sodium tablets as subpotent, covering 12 products together for the same reason.
Published
2026-07-29
Document no.
D-0700-2026
Companies
Major Pharmaceuticals
Product
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61 외 11품목
Class
Class II
All 12 products
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
Original text and translation · representative case
Subpotent Drug
Key facts · Basis: official source record kept by the collector
Reason: subpotent drug
Scope: 12 products recalled together for the same reason
Class: Class II
Firm: Major Pharmaceuticals, issued 29 July 2026
Insight · Editorial insight
That the subpotency appeared across several products rather than at one strength suggests a question that needs checking over a wider range than a single batch. Firms handling narrow therapeutic index products should confirm their in-process control indicators for content uniformity and their assay trend data through the shelf life.
Check points
In-process control indicators for content uniformity of narrow therapeutic index products
Frequency of review of assay decline trends within the shelf life
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 12 products into one entry. All values below refer to one representative product (including lots, quantity, and status).
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-07-13FDA classification · 2026-07-17FDA published · 2026-07-29
Manufacture and distribution: manufactured by Alkem Laboratories Ltd. in India, distributed by Ascend Laboratories, LLC
Class: Class II
Insight · Editorial insight
This is a combination tablet where dissolution failure and low content appeared together, and two attributes moving out at once can generally be linked to formulation and process variables. Firms having combination tablets made overseas under contract should confirm dissolution trends in stability testing and the history of process change notifications from the contract site.
Check points
Dissolution trend in stability testing of the combination tablet
History of process change notifications from the contract site and the impact assessments made
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-07-08FDA classification · 2026-07-20FDA published · 2026-07-29
Affected lots and expiry
Original · OpenFDA
Lot 25121311, expiry 3/31/2028
Recall size and scope
Quantity — 6,192 bottles
Distribution — Nationwide in the USA
Company location — Bedminster, NJ, United States
Product identification
Brand name — AMLODIPINE AND OLMESARTAN MEDOXOMIL
Generic name — AMLODIPINE AND OLMESARTAN MEDOXOMIL
Active ingredient — AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL
Rohto-Mentholatum (Vietnam) Co., Ltd. recalled eye drops for lack of assurance of sterility, covering eight products together for the same reason.
Published
2026-07-29
Document no.
D-0715-2026
Companies
Rohto-Mentholatum (Vietnam) Co., Ltd.
Product
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1 외 7품목
Class
Class II
All 8 products
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Original text and translation · representative case
Lack of Assurance of Sterility
Key facts · Basis: official source record kept by the collector
Reason: lack of assurance of sterility
Scope: eight products recalled together for the same reason
Product family: sterile eye drops in 13 mL presentations, distributed by The Mentholatum Company
Class: Class II
Insight · Editorial insight
In an ophthalmic dosage form that must be sterile, the lack of sterility assurance extended across the whole product family rather than one product. Firms producing or importing sterile dosage forms should confirm the valid scope of their aseptic process validation and which products their container closure integrity data actually covers.
Check points
Validity period and scope of the aseptic process validation, including media fills
The range of products covered by container closure integrity test data
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 8 products into one entry. All values below refer to one representative product (including lots, quantity, and status).
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-07-14FDA classification · 2026-07-23FDA published · 2026-07-29
Affected lots and expiry
Original · OpenFDA
Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.
Recall size and scope
Quantity — 1.033,266 cartons
Distribution — Nationwide within the United States
Company location — Ho Chi Minh, Vietnam
Product identification
Brand name — ROHTO
Generic name — HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE
Active ingredient — HYPROMELLOSE, UNSPECIFIED, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE, UNSPECIFIED FORM
[Recall · FDA]Rising Pharma Holding, Inc. — Crystallisation and floating particles in syrup
Evidence AFDASignal Med · T2💊 Small moleculeRecall
Rising Pharma Holding, Inc. recalled cyproheptadine hydrochloride syrup because the medication was crystallising and particles were floating in the bottle.
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Key facts · Basis: official source record kept by the collector
Reason: presence of precipitate - the medication was crystallising and particles were floating in the bottle
Product: Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (NDC 64980-504-48)
Manufacture and sale: manufactured by Lyne Laboratories, Inc. in Brockton, MA and sold by Rising Pharma Holdings, Inc.
Class: Class II
Insight · Editorial insight
Precipitation in a liquid dosage form can generally be linked to the solubility limit and storage temperature, and as here it is often only found once the product is in distribution. Firms handling syrups should review whether the stability test panel includes appearance and precipitation, and whether precipitation has been checked at the lower end of the labelled storage range.
Check points
Whether appearance and precipitation attributes are set in the stability test panel for syrups
Data confirming behaviour at the lower limit of the labelled storage temperature
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-07-13FDA classification · 2026-07-23FDA published · 2026-07-29
[Recall · FDA]Fresenius Kabi USA, LLC Glycopyrrolate Injection, USP, 1 mg… — Hair found in an injection
Evidence AFDASignal Med · T2💊 Small moleculeRecall
Fresenius Kabi USA, LLC recalled glycopyrrolate injection after hair was found in the product, covering five products together for the same reason.
Published
2026-07-29
Document no.
D-0725-2026
Companies
Fresenius Kabi USA, LLC
Product
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07 외 4품목
Class
Class II
All 5 products
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
Original text and translation · representative case
Presence of Particulate Matter: Hair was found in product
Key facts · Basis: official source record kept by the collector
Reason: presence of particulate matter - hair was found in the product
Scope: five products recalled together for the same reason
Product: Glycopyrrolate Injection, USP, 1 mg per 5 mL multiple dose vials among other injectables
Class: Class II
Insight · Editorial insight
Hair detected in an injection can generally be linked to personnel gowning and to control of personnel intervention in the filling area. Firms running injectable lines should confirm how effective the gowning procedure is, the records of interventions in the filling area, and the sensitivity of final visual inspection to particulate.
Check points
Gowning procedure and records of personnel intervention in the aseptic filling area
Acceptance criteria for particulate at final visual inspection and qualification of the inspectors
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 5 products into one entry. All values below refer to one representative product (including lots, quantity, and status).
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-07-16FDA classification · 2026-07-23FDA published · 2026-07-29
Affected lots and expiry
Original · OpenFDA
Lot #: 6134349, 6134620 Exp. Date 11/2026
Recall size and scope
Quantity — 59,425 vials
Distribution — Nationwide within in the USA
Company location — Lake Zurich, IL, United States
Product identification
Brand name — GLYCOPYRROLATE
Generic name — GLYCOPYRROLATE
Route of administration — INTRAMUSCULAR, INTRAVENOUS
[Recall · FDA]Precision Dose Inc. — Unidentified impurity out of specification
Evidence AFDASignal Med · T2💊 Small moleculeRecall
Precision Dose Inc. started a recall of glycopyrrolate oral solution after an out-of-specification result for an unidentified impurity was found during routine stability testing.
Routine stability testing was the trigger for the recall here, showing that an unidentified impurity with no individual limit still has to be controlled against the unspecified impurity limit. Firms should confirm that the stability programme for liquid dosage forms sets an unspecified impurity limit and an identification threshold.
Check points
Unspecified impurity limit and identification threshold in the stability specification
Procedure for deciding on recall of distributed stock when a stability result is out of specification
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-07-14FDA published · 2026-07-29
Affected lots and expiry
Original · OpenFDA
Lot # 506033, Exp Date: 11/30/2026.
Recall size and scope
Distribution — US Nationwide.
Company location — South Beloit, IL, United States
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