Global Regulatory Monitor Regulatory News, Week 3 · 2026/9
Period 2026-09-14 ~ 2026-09-21Published 2026-09-21Collected 107 · 38 cardsEvidence A 33 · B 5 · C 0
24 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 a Bausch & Lomb site over inadequate aseptic processing environmental control
Health Canada recalls two lots of Teva-Pregabalin 150 mg capsules as Type I over cross-contamination with sertraline
MFDS suspends manufacture of a mouthwash product for one year after its active ingredient measured 69.2% of the labelled amount
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]Bausch & Lomb Inc. — Aseptic contamination control cited
Evidence BFDASignal High · T3CGMP
FDA issued a warning letter to Bausch & Lomb Inc. after a March 12 to 20, 2026 inspection of its drug manufacturing facility in Tampa, Florida, citing CGMP violations in aseptic processing environmental control and aseptic procedures.
Published
2026-09-15
Document no.
6266b6a5dbe5
Company / site
Bausch & Lomb Inc.
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 09/04/2026
Key facts · Basis: official index plus supporting sources
Violation 1: failure to perform operations within specifically defined areas of adequate size and to have controls necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10))
Violation 2: failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes (21 CFR 211.113(b))
Basis: out-of-limit recoveries from aseptic ISO 5 areas routinely observed from 2023 to 2025, including Serratia marcescens and Stenotrophomonas maltophilia, and a media fill failure on line 16 in July 2025
Action: written response required within fifteen (15) business days of receipt (FEI 1000113778)
Insight · Editorial insight
FDA is treating environmental monitoring data as evidence that has to be investigated to its source rather than merely tabulated. Because water-associated gram-negative organisms recurred in ISO 5 areas and the same genus and species appeared in consumer complaint samples, sterile operations elsewhere are read the same way: whether EM excursions lead to organism identification, trending and CAPA.
Check points
Procedure for organism identification and trend investigation when ISO 5 environmental or personnel monitoring limits are exceeded
Whether media fill size represents actual commercial batch size and aseptic intervention risk
Whether smoke studies on aseptic filling lines are performed under dynamic conditions
Violation detail · 2 items · From the source
Violation 121 CFR 211.42(c)(10)
Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).
Violation 221 CFR 211.113(b)
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
[Regulatory news · EMA]Meeting highlights from the Committee for Medicinal Products… — September CHMP recommends 12
Evidence BEMASignal Med · T2GMP News
EMA published the meeting highlights of its Committee for Medicinal Products for Human Use (CHMP) for 14-17 September 2026. The committee recommended 12 medicines for approval at that meeting.
Published
2026-09-18
Document no.
5f5b8279859d
Issuing authority
EMA
Topic
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP…
Key facts · Basis: official index plus supporting sources
Meeting: CHMP, 14-17 September 2026
Outcome: 12 new medicines recommended for approval
Format: meeting highlights together with key CHMP statistics
Insight · Editorial insight
The monthly CHMP highlights are a regular read on the EU approval pipeline. Whether an in-licensed or contract-manufactured product appears on the recommendation list can move EU supply and change-control timing, so the value of this item is at the individual product level.
Check points
Whether any recommended product is in-licensed or exported by your organisation
Review the EMA source for the per-product recommendation detail
[Guidance · FDA]Target Animal Safety Evaluation for Veterinary Monoclonal An… — Veterinary mAb safety draft
Evidence AFDASignal Med · T2Guidance
FDA announced the availability of draft guidance for industry (GFI) #298 (VICH GL62) on target animal safety evaluation for veterinary monoclonal antibody products.
Published
2026-09-18
Document no.
2026-19141
Issuing authority
FDA
Topic
Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Dra…
Original text and translation
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products.
Key facts · Basis: official source record kept by the collector
Document: draft guidance for industry GFI #298 (VICH GL62)
Subject: target animal safety evaluation for veterinary monoclonal antibody products
Status: draft issued for availability; the comment deadline is not confirmed from the input received
Insight · Editorial insight
Safety evaluation expectations for veterinary biologics are being consolidated through VICH-harmonised text. For developers and contract manufacturers of veterinary antibodies, the scope of safety data such a harmonised draft asks for sets the frame of the development plan.
Check points
Scope of target animal safety data assembled for veterinary antibody products
How the VICH-harmonised guidance is taken up in the local regulatory route
[Guidance · FDA]Biosimilar User Fee Act III Future Needs in the Development… — Interchangeable products strategy
Evidence AFDASignal Med · T2Guidance
FDA announced the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document".
Published
2026-09-18
Document no.
2026-19166
Issuing authority
FDA
Topic
Biosimilar User Fee Act III Future Needs in the Development of Interchangeable P…
Original text and translation
The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document).
Key facts · Basis: official source record kept by the collector
Document: draft strategy document from the BsUFA III post-workshop process
Subject: future needs in the development of interchangeable products
Status: draft published
Insight · Editorial insight
US expectations for interchangeable biosimilar development are being reworked inside the user-fee framework rather than through a standalone guidance. For anyone developing or supplying biosimilars to the US, where the data burden for interchangeability settles feeds straight into CMC and quality strategy.
Check points
Revisit the interchangeability strategy for biosimilars in the portfolio
Confirm the data expectations set out in the draft strategy document
[Guidance · FDA]Agency Information Collection Activities; Submission for Off… — Biological deviation reporting notice
Evidence AFDASignal Med · T2Guidance
FDA announced that a proposed information collection covering the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations in manufacturing has been submitted to OMB for review and clearance, and invited comment.
Published
2026-09-16
Document no.
2026-18946
Issuing authority
FDA
Topic
Agency Information Collection Activities; Submission for Office of Management an…
Original text and translation
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Key facts · Basis: official source record kept by the collector
Process: information collection submitted for review and clearance under the Paperwork Reduction Act of 1995, with comment requested
Coverage: reporting of biological product deviations and of HCT/P deviations in manufacturing
Status: under Office of Management and Budget (OMB) review
Insight · Editorial insight
Manufacturing deviation reporting for biological products is being maintained and renewed as a standing US obligation rather than reconsidered. For suppliers of biological or cell- and tissue-based products to the US market, what matters is whether the reportability decision and its deadline are carried by documented steps inside the quality system.
Check points
Criteria used to decide whether a manufacturing deviation is reportable for biological products
Deadline tracking and record retention for deviation reports
[Regulatory news · EMA]International collaboration on GMP inspections — International GMP inspection work
Evidence BEMASignal Med · T2GMP News
EMA published material on international collaboration in GMP inspections. What we received is at headline level, so the detail needs to be read at the source.
Published
2026-09-14
Document no.
59e513e60f06
Issuing authority
EMA
Topic
International collaboration on GMP inspections
Key facts · Basis: official index plus supporting sources
Subject: international collaboration on GMP inspections
Publisher: EMA, 14 September 2026
Detail: the body text was not captured on our side, so the source needs to be read
Insight · Editorial insight
The item sits on the trend of regulators making joint use of each other's GMP inspection outcomes. The wider the route by which an inspection outcome travels between authorities, the wider the spread of a single site's findings across markets.
Check points
Confirm at the EMA source which authorities and what scope the collaboration covers
Consider whether your own site inspection outcomes may be shared across jurisdictions
[WHO · WHO]Zydus Lifesciences (Khundaim Industrial Estate) — Oral solid dose site found compliant
Evidence BWHOSignal Med · T2WHO
WHO published a public inspection report (WHOPIR) on the Zydus Lifesciences Limited site at Kundaim Industrial Estate, Goa, India. The site was considered to be operating at an acceptable level of compliance with the WHO Good Manufacturing Practices for Finished Pharmaceutical Products guidelines.
Inspection date
2026-06-29
Document no.
who-whopir-9b3a402e7fc3
Topic
Zydus Lifesciences (Khundaim Industrial Estate)
Issuing authority
WHO
Key facts · Basis: official index plus supporting sources
Inspection date: 29 June 2026
Outcome: considered to be operating at an acceptable level of compliance with WHO GMP for Finished Pharmaceutical Products
Deficiencies: those observed during the inspection were addressed to a satisfactory level before publication of the WHOPIR
Validity: 3 years, provided the outcome of any inspection conducted during that period is positive
Insight · Editorial insight
Even on an acceptable outcome, a WHOPIR sets out what was seen per system - quality system, premises, documentation, quality control - which is why it works as supplier-assessment material. For anyone carrying an Indian oral solid dose site in their supply chain, those section narratives give something concrete to hold a supplier questionnaire against.
Check points
Confirm whether the site appears in your own supply chain
Feed the per-section narrative of the WHOPIR into supplier assessment records
Inspection report detail · From the source · WHO · Item 17
Inspection outcome
Original · WHOPIR
Based on the areas inspected, the people met and the documents reviewed, and considering the findings of the inspection, including the observations listed in the Inspection Report, Zydus Lifesciences Limited, located at Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa- 403115, India, was considered to be operating at an acceptable level of compliance with the WHO Good Manufacturing Practices for Finished Pharmaceutical Products guidelines. The deficiencies observed during the inspection, as listed in the full report, were addressed by the Zydus Lifesciences Limited to a satisfactory level before the publication of the WHOPIR. This WHOPIR will remain valid for 3 years, provided that the outcome of any inspection conducted during this period is positive
1. Pharmaceutical quality system
Original · WHOPIR
General The Quality Assurance system was designed to ensure that finished pharmaceutical products meet current quality standards, with clearly defined responsibilities for all key personnel. QA and Quality Control functions operated independently, reporting to Head Technical Services and maintaining oversight from Central Quality. Site quality governance was defined through established SOPs. …
2. Good manufacturing practices for pharmaceutical products
Original · WHOPIR
The site maintained a GMP-compliant quality management system to ensure that pharmaceutical products were consistently manufactured and controlled in accordance with regulatory requirements and marketing authorizations. The GMP system aimed to minimize manufacturing risks and ensure product quality, safety, and efficacy. Manufacturing processes were clearly defined, validated, and systematically reviewed to confirm compliance with established specifications. …
3. Sanitation and hygiene
Original · WHOPIR
The sanitation and hygiene practices were maintained in all aspects of medicinal product manufacturing. These practices covered personnel, premises, equipment, production materials, containers, and cleaning agents, in accordance with SOP for Cleaning, Sanitization, Fogging of Area and Handling of Cleaning Aids in the OSD Area. The SOP included a list of approved disinfectants, and the applicable efficacy testing had been performed. The applicable documentation was selected and reviewed.
4. Qualification and validation
Original · WHOPIR
Validation Master Plan The site had established a Validation Master Plan (VMP) for the manufacturing facilities, including the OSD Plant and a Computer System Validation Master Plan (CSVMP) for the Formulation and Anticancer Plant. The VMP defined the overall validation and qualification strategy for facilities, utilities, equipment, products, processes, computerized systems, and other GMP support activities that could impact product quality. …
5. Quality Complaints
Original · WHOPIR
Complaints related to potentially defective products were reviewed in accordance with the applicable SOP, effective 19/05/2026, and corrective and preventive actions were implemented as necessary. The Head of QA, supported by appropriately qualified personnel, was responsible for complaint handling and decision-making. The SOP described the actions required for complaint management, including the assessment of the need for product recall. Investigations were conducted to determine whether a product defect existed, and all complaints were documented and reviewed by the Quality Control Unit. …
6. Product recalls
Original · WHOPIR
A system was in place to ensure the prompt and effective recall of products known or suspected to be defective, in accordance with the applicable SOP, effective 02/05/2026. List of recalls, and randomly selected documentation were reviewed and discussed. Mock recalls were required to be performed every two years unless an actual product recall occurred during the preceding two-year period.
7. Contract production, analysis and other activities
Original · WHOPIR
The Company had quality control services contracted out. However, no manufacturing or other GMP activities were contracted out. A written contract was established between the contract giver and the contract acceptor, clearly defining the responsibilities of each party, including outsourced activities, communication, and technical arrangements. The contract permitted the contract giver to audit the facilities and activities of the contract acceptor or mutually agreed subcontractors.
8. Self-inspection, quality audits and suppliers’ audits and approval
Original · WHOPIR
Self-inspections were conducted in accordance with the respective SOP, effective 25 February 2026. Routine self-inspections were performed every six months, while additional inspections could be initiated in response to specific events such as product recalls, critical market complaints, critical deviations or non-conformances, review of quality metrics, or regulatory inspections. Inspections were carried out by a qualified audit team operating independently and objectively to verify compliance with GMP requirements. …
9. Personnel
Original · WHOPIR
The site maintained a defined organizational structure covering Quality Management, Production, Quality Control, Storage, and Distribution activities. Organizational charts detailing key functions, reporting relationships, and responsibilities were available and were discussed during the inspection. The organizational structure, staffing levels, and qualification framework were considered adequate to support the manufacture, testing, storage, and distribution of pharmaceutical products while ensuring compliance with GMP requirements. …
10. Training
Original · WHOPIR
Personnel training management and employee qualification were governed by an SOP, which defined the requirements for identifying, planning, delivering, documenting, and evaluating training activities. The training programme was designed to ensure that employees remained qualified for their assigned responsibilities and that competency was maintained throughout their employment. Training requirements were established through a Training Need Identification (TNI) process. …
11. Personal hygiene
Original · WHOPIR
SOP for Exit Procedure Involving Primary Garment Change and Personnel Hygiene for OSD-II, effective 25/06/2026, was reviewed. Pictorial instructions for hand washing and sanitization, gowning, and de-gowning were displayed at strategic locations. Personnel underwent medical examinations before and during employment, including periodic eye examinations for employees performing visual inspection activities, in accordance with the applicable SOP effective 25/03/2026. …
12. Premises
Original · WHOPIR
A site layout, including an area classification layout, was provided and discussed during the inspection. The inspection scope was limited to OSD Block II, where all current Oral Solid Dosage manufacturing activities were performed. OSD Block I was not included within the inspection scope, as it was no longer operational and had been taken out of service pending maintenance and expansion activities. A layout drawing showing OSD Block I, OSD Block II, and the associated manufacturing and packaging lines was available and reviewed. …
13. Equipment
Original · WHOPIR
Process Equipment Operation and Qualification The operation of process equipment was governed by operating manuals and activities recorded in a software system. The following operating manuals were discussed: − Operation of Tablet Coating Machine − Operation of Filling Machine Equipment and instruments used for dispensing, manufacturing, packing, testing, and other processes were qualified before operational use. …
14. Materials
Original · WHOPIR
Written procedures were available for the receipt, handling, and storage of incoming raw materials under applicable procedures. The automated warehouse was common for raw materials, primary packing materials, secondary packing materials, and finished goods. Incoming consignments were visually examined on receipt. Damaged or improperly labelled goods were segregated and referred to Quality Assurance for further instructions regarding disposal or return. …
15. Documentation
Original · WHOPIR
Document Management The documentation system was controlled through approved procedures for document creation, review, approval, issue, revision, withdrawal, retention and archiving. The documents were handled in electronic, paper-based, or hybrid form. Current authorized versions of procedures and forms were available at the points of use, and obsolete documents were prevented from unintended use. The reviewed Batch manufacturing and packaging records were noted to be sufficiently detailed to reconstruct operations and demonstrate compliance with approved instructions. …
16. Good Manufacturing Practices in production
Original · WHOPIR
Production was performed in accordance with approved Batch Manufacturing Records (BMRs), with records completed contemporaneously with the activities performed. Reconciliation was conducted at critical stages of manufacture and upon completion of packaging operations. The Production Department was responsible for the preparation and review of SOPs and master BMRs, manufacture and packaging in accordance with approved batch records and SOPs, maintenance of online documentation, personnel training, performance of in-process controls, batch record review, deviation reporting, and execution of pro …
17. Good practices in quality control
Original · WHOPIR
The site had dedicated physicochemical and microbiology laboratories, a control sample area and a stability area. Quality Assurance and Quality Control functions were independent, and their responsibilities and governance were defined in the site quality governance SOP. The QC laboratory was responsible for sampling and testing of raw materials, packing materials, in- process samples, and finished goods for physical, chemical, and microbiological parameters against approved specifications and test methods. …
[WHO · WHO]Egypt - EDA-CADC — Control laboratory found compliant
Evidence BWHOSignal Med · T2WHO
WHO published a public inspection report (WHOPIR) on the Egyptian Drug Authority - Central Administration for Drug Control laboratory in Giza, Egypt. The laboratory was considered to be operating at an acceptable level of compliance with the WHO Good Practices for Pharmaceutical Quality Control Laboratories guidelines.
Inspection date
2026-04-27
Document no.
who-whopir-c4e851557551
Topic
Egypt - EDA-CADC
Issuing authority
WHO
Key facts · Basis: official index plus supporting sources
Inspection date: 27 April 2026
Subject: the Egyptian Drug Authority - Central Administration for Drug Control laboratory
Outcome: considered to be operating at an acceptable level of compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories
Validity: 3 years, provided the outcome of any inspection conducted during that period is positive
Insight · Editorial insight
The report shows that an authority's own official control laboratory is itself inspected against WHO standards and the result made public. Where post-market sampling and testing for an exported product runs through this laboratory, the sample-handling and testing arrangements described in the report are what your own results would be compared against.
Check points
Confirm the local sampling and testing route for products exported to Egypt
Review the laboratory operations described in the WHOPIR
Inspection report detail · From the source · WHO · Item 5
Inspection outcome
Original · WHOPIR
– Conclusion – Inspection outcome Based on the areas inspected, the people met and the documents reviewed, and considering the findings of the inspection, including the observations listed in the Inspection Report of Egyptian Drug Authority - Central Administration for Drug Control, located at Elmansoureya Street, Haram, Giza; Egypt was considered to be operating at an acceptable level of compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories guidelines. The deficiencies observed during the inspection, as listed in the full report, were addressed by the Laboratory to a satisfactory level before the publication of the WHOPIR. This WHOPIR will remain valid for 3 years, provided that the outcome of any inspection conducted during this period is positive.
1. Organization and management
Original · WHOPIR
A presentation detailing the Laboratory history and activities was provided during the opening meeting. 1.1. Structural and general requirements The Laboratory was legally authorized by the Egyptian Drug Authority (EDA) to perform testing and issue certificates of analysis. It was responsible for the validity of all results and activities performed. Senior management ensured the establishment, implementation, and maintenance of an effective quality management system, including a data governance system, by providing appropriate policies, training, and technical infrastructure. …
2. Planning and strategic management
Original · WHOPIR
2.1. Externally provided services and supplies The system used to define, review, and approve requirements for outsourced services or products required by the EDA, including criteria for selection, performance monitoring, evaluation, and re-evaluation of service providers to ensure compliance with requirements, was described in SOP Outsourcing and Technical Evaluation of EDA Provided Products/Services, current version last issued on 23 April 2025. A governmental portal listed all pre-approved service providers that could be used by the laboratory for selection. …
3. Resources
Original · WHOPIR
3.1. Personnel Personnel with the required education, training, technical knowledge, and experience for their assigned functions were employed, either permanently or on a contractual basis. Competence requirements for each function were documented, and procedures and criteria for selecting and assessing personnel competence were established in accordance with the QMS. Staff undergoing training were supervised and assessed upon completion, with assessments fully documented. …
4. Technical activities
Original · WHOPIR
4.1. Sampling The laboratory was not responsible for sampling. Samples were collected by authority inspectors from pharmacies, distributors, or manufacturing sites and delivered to the Laboratory at the Agouza site. The Agouza laboratory registered the samples in LIMS as either marketing authorization or post-marketing samples, including relevant details such as specifications and required tests. A unique identification number was assigned to each sample. 4.2. …
5. Safety rules
Original · WHOPIR
A tour of the facility was conducted on the first day. A documented laboratory safety policy, including general and specific safety instructions reflecting identified risks, was available and applied by staff. A designated staff member was responsible for overseeing the policy and ensuring compliance. A waste management system compliant with local legislation was in place to ensure the safe disposal of chemicals, solvents, and other relevant materials. Training on safety-related topics was conducted at defined intervals, as specified in the QMS. …
MFDS published the outcome of a follow-up inspection of Janssen-Ortho LLC in Puerto Rico. One deficiency was raised in the laboratory area and is recorded as remediated.
Published
2026-09-15
Document no.
gmpinspect-1Q2a5UEfhl1
Site
Janssen-Ortho LLC
Inspection period
2026-03-10~2026-03-12
Original text
평가 결과: 지적(보완)사항(Deficiencies) 있음 분야1) 구분2) 근거 법령 지적(보완)사항 요약 비고 시험실 기타 [별표 1] 제7.1호 조제 시액에 대한 유효기간 설정 근거를 마련할 것 보완완료 1) GMP 감시 분야(6개): 품질, 시설장비, 제조, 시험실, 원자재, 포장표시 2) PIC/S 정의에 따라 중대, 중요, 기타로 작성 제형 비고 비무균-일반제제-내용고형제 완제
Key facts · Basis: official source record kept by the collector
Inspection: 10-12 March 2026, follow-up inspection of a single finished-product site
Deficiency: laboratory area, other category, Annex 1 item 7.1 - establish the basis for the expiry period assigned to prepared reagent solutions (remediation completed)
The point at issue is the documented basis for the expiry period of solutions prepared in-house. Unlike reference standards or purchased reagents, prepared solutions often carry no recorded rationale for their use-by date, which is the first link to break when a test result is traced backwards.
Check points
Whether the expiry basis for laboratory-prepared solutions is documented
Records of re-preparation or disposal once a prepared solution passes its use-by date
[GMP inspection · MFDS]FAREVA Amboise — Sterilisation and seal testing
Evidence AMFDSSignal High · T3GMP inspection
MFDS published the outcome of a follow-up inspection of FAREVA Amboise in France. Deficiencies were raised in the facilities/equipment and production areas, centred on sterilisation equipment control and seal testing.
Published
2026-09-15
Document no.
gmpinspect-1Q2aMMjWSti
Site
FAREVA Amboise
Inspection period
2026-03-31~2026-04-02
Original text
평가 결과: 지적(보완)사항(Deficiencies) 있음 분야1) 구분2) 근거 법령 지적(보완)사항 요약 비고 시설장비 기타 [별표 1] 제2.1호 멸균 공정에 사용되는 장비의 밸리데이션 및 점검 방법·주기와 제품 오염 방지 관리 방안 등을 타당하게 마련할 것 시설장비 기타 [별표 1] 제9호 칭량도구의 세척, 제조설비 유지관리 등 작업 시 오염 위험이 없도록 관리방안을 마련할 것 제조 기타 [별표 1] 제8.1호 밀봉시험방법의 적합성을 확…
Key facts · Basis: official source record kept by the collector
Inspection: 31 March to 2 April 2026, follow-up inspection of a single finished-product site
Deficiency (facilities/equipment): Annex 1 item 2.1 - establish a sound basis for validation and inspection methods and intervals for sterilisation equipment, and for controls preventing product contamination
Deficiency (facilities/equipment): Annex 1 item 9 - establish controls so that cleaning of weighing tools and maintenance of production equipment do not create contamination risk
Deficiency (production): Annex 1 item 8.1 - submit data confirming the suitability of the seal test method, and a sound justification for not performing seal testing after sterilisation
Insight · Editorial insight
Sterilisation equipment validation and post-sterilisation seal testing being cited together reads as an unsettled answer to where container closure integrity is actually secured. Choosing not to perform seal testing after sterilisation can be defensible, but with no documented justification it stands as a gap in the process design.
Check points
Validation and inspection intervals for sterilisation equipment, and the associated contamination controls
Data supporting the suitability of the seal test method
Documented justification where seal testing is not performed after sterilisation
[GMP inspection · MFDS]보란파마 — Data integrity clarification
Evidence AMFDSSignal Med · T2🧬 BiologicsGMP inspection
MFDS published the outcome of a follow-up inspection of a domestic finished-product manufacturing site. A deficiency in the quality management area called for further explanatory material on data integrity controls.
Published
2026-09-14
Document no.
gmpinspect-1Q2TqD05rgw
Site
보란파마
Inspection period
2026-03-30~2026-04-02
Original text
평가 결과 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약 비고3) 품질 경영 기타 [별표 1] 제1의2호 데이터 완전성 관리(복구 검증 등)에 대한 추가 설명 자료를 제출할 것.
Key facts · Basis: official source record kept by the collector
Inspection: 30 March to 2 April 2026, follow-up inspection of a single finished-product site
Deficiency: quality management area, other category, Annex 1 item 1-2 - submit further explanatory material on data integrity controls, including restoration verification
Location: Gyeonggi Province, Republic of Korea
Insight · Editorial insight
What the finding reaches for is backup restoration verification rather than record-keeping practice. Backups may run, but with no record confirming that a restored copy matches the original, the claim that data has been preserved is itself unverified.
Check points
Whether restoration of electronic record backups is verified and the verification retained
The system inventory to which the data integrity procedure is applied
[GMP inspection · MFDS]엠에프씨주식회사 — API site data and release
Evidence AMFDSSignal Med · T2GMP inspection
MFDS published the outcome of a follow-up inspection of a domestic active pharmaceutical ingredient site. Deficiencies in quality management and facilities/equipment called for further material on data integrity, batch release approval and dispensing tools; remediation is recorded as completed.
Published
2026-09-14
Document no.
gmpinspect-1Q2TqD05w-H
Site
엠에프씨주식회사
Inspection period
2026-05-11~2026-05-13
Original text
①평가 결과 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약 비고3) 품질 경영 기타 [별표 1의2] 제2.1호 나목 각 제조 설비 및 품질분석기기의 데이터 완전성 관련 추가 설명 자료를 제출할 것.
②보완 완료 기타 [별표 1의2] 제2.2호 제품의 출하 승인 및 제조지시 업무 절차 관련 추가 설명 자료를 제출할 것.
Key facts · Basis: official source record kept by the collector
Inspection: 11-13 May 2026, follow-up inspection of a single API site
Deficiency: quality management, Annex 1-2 item 2.1(b) - submit further explanatory material on data integrity for each item of production equipment and quality analysis instrumentation (remediation completed)
Deficiency: Annex 1-2 item 2.2 - submit further explanatory material on the procedures for batch release approval and manufacturing instructions (remediation completed)
Deficiency: facilities/equipment, Annex 1-2 item 5(k) - submit further explanatory material on dispensing tools and equipment
Insight · Editorial insight
The data integrity request is aimed at individual pieces of production equipment and analytical instrumentation rather than at computerised systems in the abstract. API sites carry many stand-alone instruments whose audit trails and access rights fall outside the managed inventory, and once that meets the release approval procedure, the traceability of the release decision moves with it.
Check points
Inventory of data integrity controls per item of production and analytical equipment
Documentation of the batch release approval and manufacturing instruction procedures
Control standards for dispensing tools and equipment
[GMP inspection · MFDS]동국생명과학(주) — WFI utilities and monitoring
Evidence AMFDSSignal Med · T2GMP inspection
MFDS published the outcome of a follow-up inspection of a domestic finished-product manufacturing site. Deficiencies in the facilities/equipment area called for further material on water-for-injection storage tank vent filters, compressed air and nitrogen testing, and environmental monitoring; the remediation plans were accepted as sound.
Published
2026-09-14
Document no.
gmpinspect-1Q2TqD05yGj
Site
동국생명과학(주)
Inspection period
2026-05-26~2026-05-29
Original text
평가 결과 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약 비고3) 시설장비 기타 [별표 1] 제2.1호 주사용수 저장 탱크 벤트필터 관리의 추가설명자료를 제출할 것 이행계획서 타당성 인정 기타 [별표 1] 제2.3호 압축공기 및 질소가스 시험(사용점, 주기, 항목 등)의 추가설명자료를 제출할 것 이행계획서 타당성 인정 기타 [별표 1] 제2.3호 가목 환경 모니터링(진행 기간, 미생물 확인 절차 등)…
Key facts · Basis: official source record kept by the collector
Inspection: 26-29 May 2026, follow-up inspection of a single finished-product site
Deficiency: facilities/equipment, Annex 1 item 2.1 - submit further explanatory material on control of the water-for-injection storage tank vent filter (remediation plan accepted)
Deficiency: Annex 1 item 2.3 - submit further explanatory material on compressed air and nitrogen testing, covering use points, intervals and parameters (remediation plan accepted)
Deficiency: Annex 1 item 2.3(a) - submit further explanatory material on environmental monitoring, covering monitoring periods and microbial identification procedures (remediation plan accepted)
Insight · Editorial insight
All three findings sit on the same axis: utilities - water for injection, process gases and the monitored environment. Utilities do not surface directly in product testing, so the rationale behind their intervals and test parameters tends to loosen, and for a component such as a vent filter that blocks a contamination route outright, that looseness is the risk itself.
Check points
Integrity test interval and records for the water-for-injection storage tank vent filter
Basis for use points, intervals and test parameters for compressed air and nitrogen
Environmental monitoring periods and the microbial identification procedure
[GMP inspection · MFDS]크로다코리아주식회사 — Manufacturing records falsified
Evidence AMFDSSignal Med · T2GMP inspection
MFDS published the outcome of a follow-up inspection of a domestic active pharmaceutical ingredient site. Manufacturing instructions and records having been completed inconsistently with the facts was cited as a major deficiency; remediation is recorded as completed.
Published
2026-09-11
Document no.
gmpinspect-1Q2F5hAXd12
Site
크로다코리아주식회사
Inspection period
2026-05-06~2026-05-08
Original text
평가 결과 지적(보완)사항(Deficiencies) 분야 1) 구분 2) 근거 법령 지적(보완)사항 요약 비고 3) 제조 중요 [별표 1의2] 제8.1호 가목 제조지시 및 기록서를 사실과 다르게 작성한 사항에 대한 시정조치, 재발방지대책을 마련하고, 제조 기록 철저 필요 보완 완료 기타 [별표 1의2] 제2.3호 나목 제조부서책임자의 제조지시서 승인, 점검·확인, 작업자의 제조지시서 승인 확인에 대한 절차 명확화 필요 보완 완료 기타 [별표 1…
Key facts · Basis: official source record kept by the collector
Inspection: 6-8 May 2026, follow-up inspection of a single API site
Deficiency (major): production area, Annex 1-2 item 8.1(a) - establish corrective action and recurrence prevention for manufacturing instructions and records completed inconsistently with the facts, and ensure manufacturing records are kept rigorously (remediation completed)
Deficiency (other): Annex 1-2 item 2.3(b) - clarify the procedure for the production manager's approval and verification of manufacturing instructions, and for operator acknowledgement (remediation completed)
Deficiency (other): Annex 1-2 item 8.2 - controls for the API blending process are insufficiently reflected in the site's own standards
Insight · Editorial insight
A record inconsistent with the facts was graded major and sits alongside an unclear approval and verification step for the same manufacturing instruction. Record reliability problems usually grow out of a procedure with an empty verification stage rather than out of individual habit, so a corrective action that stops at retraining leaves room for the same pattern to return.
Check points
Named responsibility at each stage of preparing, approving and verifying manufacturing instructions and records
Effectiveness check on corrective and preventive action taken after a record discrepancy
How far API blending process controls are written into the site's own standards
Key facts · Basis: official source record kept by the collector
Count: 11 inspections with no deficiencies raised
Source: MFDS published GMP inspection results
Insight · Editorial insight
An overseas solid oral site closed its follow-up inspection with no findings. There is roughly a six-month gap between the inspection dates and the publication date, so the record is best read as a snapshot rather than a warranty of the site's current state.
Check points
Check the list for your own contract manufacturing sites
[Administrative action · MFDS]한림제약(주) 외 5개사 — Re-examination data shortfall (6 companies)
Evidence AMFDSSignal High · T3💊 Small moleculeAdministrative action
MFDS issued the same administrative action against 6 domestic manufacturers on the same date. The violation, legal basis and suspension period are identical across all 6 cases; each company was penalised for a single product, listed on this card.
의약품 ‘스타펜캡슐’의 재심사에 필요한 자료의 일부를 제출하지 아니함(시판 후 조사 대상자 수 부족)
Key facts · Basis: official source record kept by the collector
Violation: part of the data required for the product's re-examination was not submitted, the shortfall being an insufficient number of post-marketing surveillance subjects
Action: three-month suspension of sales of the product concerned, from 28 September 2026 to 27 December 2026
Legal basis: former Pharmaceutical Affairs Act Article 32 and former Rules on the Safety of Drugs Article 23
Insight · Editorial insight
What failed here is a quantitative requirement - the number of post-marketing surveillance subjects - rather than the existence of a dossier. Case numbers cannot be made up once the re-examination period has closed, so whether enrolment progress is checked mid-period is what separates a clean filing from a sales suspension.
Check points
Tracking of post-marketing surveillance case accrual for products subject to re-examination
Alignment between the re-examination submission deadline and the close of the surveillance period
Evidence AMFDSSignal High · T3Administrative action
MFDS found that a domestic manufacturer had produced and sold a mouthwash quasi-drug whose active ingredient content fell outside specification on post-market sampling and testing, and suspended manufacture of the products concerned for one year.
○ 의약외품(구중청량제) 수거·검사 부적합(유효성분 함량시험)
-「약사법」제62조 및 제66조에 따라, 누구든지 다음 각 호의 어느 하나에 해당하는 의약외품을 판매할 목적으로 제조하여서는 아니 되나,
- 동 업체는 ‘2080진지발라스가글스트롱’ 제품의 유통 의약외품 수거·검사 결과, 유효성분(염화세틸피리디늄) 함량이 기준치보다 10%이상 과부족한 제품을 제조하여 판매한 사실이 있음
* (규격) 표기량(0.05 g/ 100g)에 대하여 9…
Key facts · Basis: official source record kept by the collector
Violation: post-market sampling and testing of a mouthwash quasi-drug failed the assay for active ingredient content, with cetylpyridinium chloride more than 10% off the specified level
Result: specification is not less than 90.0% of the labelled amount (0.05 g/100 g); the result was 69.2%
Action: one-year suspension of manufacture, from 28 September 2026 to 27 September 2027; because the item is a package listing, the action applies to all 13 products in it
Legal basis: Pharmaceutical Affairs Act Articles 62 and 66
Insight · Editorial insight
An active ingredient found at 69.2% against a floor of 90.0% of label reads as content control that does not hold the lower limit, not as batch-to-batch variation. The second half of the case is the spread: because the item sits in a package listing, one product's assay failure stops manufacture across all 13 products under that listing.
Check points
Consistency between in-process content controls and the release specification for active ingredient assay
Scope of products grouped under one approval listing and the reach of an action against it
Impact assessment across products in the same listing when post-market testing fails
Evidence AMFDSSignal High · T3💊 Small moleculeAdministrative action
MFDS found a breach of the re-examination requirement for new drugs by a domestic pharmaceutical manufacturer and suspended sales of the capsule product concerned for three months.
○ 의약품 제조업자의 신약 등의 재심사 규정 위반
- 의약품 제조업자가 품목허가를 받은 의약품이「약사법」제31조제10항(신약 등)에 해당하는 경우, 그 의약품은 품목허가를 받은날로부터 4년에서 6년이 지난날로부터 3개월이내에 재심사를 받아야 하나,
- 동 업체는 ‘피타론에프캡슐’의 재심사 시 필요한 자료의 일부(시판 후 조사대상자 수 부족)를 제출하지 않은 사실이 있음
Key facts · Basis: official source record kept by the collector
Violation: part of the data required at re-examination was not submitted, the shortfall being an insufficient number of post-marketing surveillance subjects
Timing rule: re-examination must take place within three months of the point falling four to six years after product approval
Action: three-month suspension of sales of the product concerned, from 28 September 2026 to 27 December 2026; the product was approved on 3 April 2019
Insight · Editorial insight
The premise of the action is that re-examination has to land inside a narrow three-month window measured from a point four to six years after approval. The older the approval, the more easily that anchor date drops off a schedule, which is why deriving the due date automatically from the product register is what makes the control work.
Check points
Product-register tracking of re-examination due dates
Accuracy of the anchor-date calculation from the approval date
[Administrative action · MFDS]한국코러스(주) — On-going stability test missed
Evidence AMFDSSignal High · T3🧬 BiologicsAdministrative action
MFDS found that a domestic manufacturer had not carried out post-marketing stability testing on one batch of an export-only recombinant human erythropoietin pre-filled syringe product from its 2024 production, and suspended manufacture of that product for one month.
Published
2026-08-25
Document no.
admin-2026006740
Companies
한국코러스(주)
Action
○ 해당 품목 제조업무정지 1개월(2026. 9. 14. ~ 2026. 10. 13.)
- 해당 품목: ‘코로몬프리필드시린지4000IU(재조합사람에리스로포이에틴)(수출용)’
Original text
- 의약품 ‘코로몬프리필드시린지4000IU(재조합사람에리스로포이에틴)(수출용)’의 2024년 생산분에 대하여 시판 후 안정성 시험을 실시할 계획을 수립하였으나,
제조번호 24209001에 대하여 시험을 실시하지 않은 사실이 있음
Key facts · Basis: official source record kept by the collector
Violation: a post-marketing stability testing plan was established for 2024 production, but the test was not performed on batch 24209001
Action: one-month suspension of manufacture of the product concerned, from 14 September 2026 to 13 October 2026
Legal basis: Pharmaceutical Affairs Act Articles 37(1) and 38(1), and Rules on the Safety of Drugs Articles 43(1)3 and 48(9)(a)
Insight · Editorial insight
The plan existed; a specific batch dropped out at execution. On-going stability work only shows a gap if the annual plan is reconciled batch by batch against actual start records, and being an export-only product does not put it outside the scope of enforcement.
Check points
Batch-level reconciliation of the annual stability plan against actual initiation records
Criteria for selecting export-only products into the on-going stability programme
Evidence AMFDSSignal Med · T2💊 Small moleculeAdministrative action
MFDS found that a domestic manufacturer had failed to report supply records for three prescription products to the national drug information centre within the deadline, and imposed a fine of KRW 750,000 in lieu of a ten-day suspension of sales.
Published
2026-09-15
Document no.
admin-2026006815
Companies
(주)돌나라한농제약
Action
해당품목* 판매업무정지 10일 처분을 갈음한 과징금 750,000원 부과
* 뉴흑과립(약용탄), 뉴흑산(약용탄), 뉴흑캡슐200밀리그람(약용탄)
Original text
약사법 제47조의3제2항 및 같은법 시행규칙 제45조에 따라 일련번호를 부착하지 아니하는 전문의약품을 공급하는 경우에는 다음 달 말일까지 의약품 공급내역 현황을 의약품관리종합정보센터의 장에게 보고하여야 함에도 불구하고 상기 업체는 건강보험심사평가원 의약품관리종합정보센터에 상기 3개의 품목에 대한 의약품 공급내역 현황을 기한 내 보고하지 않은 사실이 있음
Key facts · Basis: official source record kept by the collector
Violation: supply records for prescription products not carrying a serial number must be reported to the head of the drug information centre by the last day of the following month; this was not done for three products
Action: a fine of KRW 750,000 imposed in lieu of a ten-day suspension of sales of the products concerned
Legal basis: Pharmaceutical Affairs Act Article 47-3 and its Enforcement Rule Article 45
Insight · Editorial insight
This is an information-submission duty unrelated to product quality, yet failing it lands as a product-level action. Products without a serial number have no automatic aggregation path, so the end-of-following-month deadline is carried by a person, and that is where the omission occurs.
Check points
Named ownership of the supply-reporting deadline for products without serial numbers
Monthly confirmation that reports to the drug information centre were filed
Evidence AMFDSSignal High · T3💊 Small moleculeRecall
A domestic manufacturer began a voluntary recall of distributed stock of a roxithromycin tablet product after an impurity exceeded its limit.
Published
2026-09-16
Document no.
recall-7abe996653c7
Companies
삼아제약(주)
Product
삼아록시트로마이신정
Original text
불순물(N-nitroso-desmethyl roxithromycin) 기준 초과에 따른 시중 유통품에 대한 영업자 회수
Key facts · Basis: official source record kept by the collector
Reason: voluntary recall of distributed stock following an impurity (N-nitroso-desmethyl roxithromycin) exceeding its limit
Recall order date: 16 September 2026; not a mandatory recall
Product: a roxithromycin tablet product
Insight · Editorial insight
The nitroso compound exceeded its limit in the finished product rather than in the starting material, and it surfaced in distributed stock rather than at release. Nitroso impurity levels can move with storage time and conditions, which makes this hard to treat as closed once assessed at approval.
Check points
When nitroso impurity assessment was performed for this class and how often it is revisited
Whether a testing plan exists for impurities in distributed samples
[Recall / sales suspension · MFDS]제이더블유신약(주) — Stability assay out of spec
Evidence AMFDSSignal High · T3Recall
A domestic manufacturer began a voluntary recall of a mupirocin ointment product after an assay result failed specification during stability testing.
Published
2026-09-14
Document no.
recall-4ebbb116d467
Companies
제이더블유신약(주)
Product
에스로반연고(무피로신)
Original text
안정성시험 중 함량시험 기준 부적합에 따른 영업자 회수
Key facts · Basis: official source record kept by the collector
Reason: voluntary recall following an out-of-specification assay result during stability testing
Recall order date: 14 September 2026; not a mandatory recall
Product: a mupirocin ointment product
Insight · Editorial insight
The failure arose during stability testing rather than at release, which means quality through the shelf life was not demonstrated. Stability data reports on batches that are already in the market, so what determines the recall scope is the procedure that traces an excursion back to the remaining distributed quantity.
Check points
Procedure for tracing distribution of a batch when a stability excursion occurs
Storage condition controls affecting assay stability in ointment products
Evidence AMFDSSignal High · T3💊 Small moleculeRecall
A domestic manufacturer began a voluntary recall of a benfotiamine tablet product over an error in the printed text on the secondary packaging.
Published
2026-09-14
Document no.
recall-55a6caf685eb
Companies
(주)서흥
Product
벤포비타맥스정
Original text
2차 포장지 표시기재 일부 단순 오기에 따른 영업자 회수
Key facts · Basis: official source record kept by the collector
Reason: voluntary recall following a simple error in part of the printed text on the secondary packaging
Recall order date: 14 September 2026; not a mandatory recall
Product: a benfotiamine tablet product
Insight · Editorial insight
The recall arises from labelling on the secondary pack rather than from product quality, so what decided it was the review step on packaging text. A labelling error that is not caught at pre-print proofing or at incoming inspection is the kind of defect that only becomes visible once stock is in the market.
Check points
Records of proofing and approval at each stage of packaging artwork
Labelling inspection points applied when printed packaging materials are received
Evidence AMFDSSignal High · T3💊 Small moleculeRecall
A domestic manufacturer began a voluntary recall of a benfotiamine tablet product. The stated reason is recorded only as a voluntary recall, so the nature of the defect needs to be confirmed at the source.
Published
2026-09-14
Document no.
recall-9942c438cdeb
Companies
(주)서흥
Product
벤포비타맥스정
Original text
자진회수
Key facts · Basis: official source record kept by the collector
Reason: voluntary recall
Recall order date: 14 September 2026; not a mandatory recall
Product: a benfotiamine tablet product
Insight · Editorial insight
Where the reason is logged only as a voluntary recall, the nature of the defect cannot be determined from the public record alone. Anyone using recall data as a supply chain risk signal is safer classifying an entry with no stated reason for follow-up rather than reading the blank as a minor cause.
Check points
Route for following up recall entries with no specific stated reason
Whether the entry relates to other recalls of the same product
A herbal medicine product was placed under recall for failing the sulfur dioxide requirement. The entry is recorded as a mandatory recall.
Published
2026-09-10
Document no.
recall-14d219f042fe
Companies
삼의제약
Product
삼의목단피
Original text
이산화황 부적합
Key facts · Basis: official source record kept by the collector
Reason: sulfur dioxide non-conformity
Recall order date: 10 September 2026; mandatory recall
Product: a moutan bark herbal medicine product
Insight · Editorial insight
Sulfur dioxide is an attribute commonly associated with the drying and storage of herbal materials, and this result falls outside its limit. For anyone using herbal starting materials, the starting point is whether attributes that finished-product testing does not reveal are written into the material specification at all.
Check points
Whether sulfur dioxide testing is included in herbal material specifications, and at what frequency
Drying and storage conditions at herbal material suppliers
A herbal medicine product was placed under recall for failing the appearance (organoleptic) requirement. The entry is recorded as a mandatory recall.
Published
2026-09-10
Document no.
recall-1df50b1152ce
Companies
삼의제약
Product
삼의방풍
Original text
성상(관능) 부적합
Key facts · Basis: official source record kept by the collector
Reason: appearance (organoleptic) non-conformity
Recall order date: 10 September 2026; mandatory recall
Product: a saposhnikovia root herbal medicine product
Insight · Editorial insight
The failure is in appearance, judged organoleptically, rather than by instrumental analysis. Organoleptic attributes split between analysts unless the acceptance basis is fixed precisely in writing, so what matters is whether reference material or photographic standards are actually in place.
Check points
Whether reference standards or photographic criteria exist for herbal appearance assessment
Qualification of organoleptic analysts and consistency of their assessments
Filtering face masks from a domestic manufacturer were placed under recall for a quality non-conformity. Two products were recalled together for the same reason, and the entry is recorded as a mandatory recall.
Published
2026-09-10
Document no.
recall-6a78ec1de46f
Companies
대풍테크
Product
비엠세상편한마스크(KF94)(대형)(흰색,검정색,노란색,녹색,연한황색,분홍색,회색) 외 1품목
Key facts · Basis: official source record kept by the collector
Reason: quality non-conformity in shape, specifically ear loop length
Scope: two products recalled together for the same reason
Recall order date: 10 September 2026; mandatory recall
Insight · Editorial insight
The failure is dimensional - ear loop length - rather than a filtration performance issue. Dimensional attributes are only caught at finished-product inspection unless they are held in-process, which is how products sharing the same tooling and materials end up inside the same recall scope.
Check points
Whether dimensional attributes are controlled in-process
How recall scope is decided across products sharing materials and processes
[Recall (Health Canada) · Health Canada][HC] Two lots of Teva-Pregabalin 150 mg capsules recalled du… — Cross-contamination Type I recall
Evidence AHealth CanadaSignal High · T3💊 Small moleculeRecall
Health Canada recalled two lots of Teva-Pregabalin 150 mg capsules over cross-contamination with the drug sertraline. The recall is classified Type I.
Published
2026-08-15
Document no.
hc-82496
Companies
미확인
Product
Teva-Pregabalin 150 mg capsules
Class
Type I
Original text and translation
Contamination
Key facts · Basis: official source record kept by the collector
Recall class: Type I, category Drugs
Issue: Contamination, described in the recall title as cross-contamination with the drug sertraline
Product: Teva-Pregabalin 150 mg capsules, two lots
What you should do: if you experience a serious allergic reaction (anaphylaxis), stop taking the affected product and seek immediate medical help by calling 9-1-1
Insight · Editorial insight
One active ingredient carried into another product drove a top-tier recall. Cross-contamination is only blocked when cleaning validation and product changeover work together, so on multi-product shared lines the basis for the residue limit at changeover is effectively what sets the size of the recall exposure.
Check points
Basis for residue limits in changeover cleaning validation on multi-product lines
If you experience a serious allergic reaction (anaphylaxis), stop taking the affected product and seek immediate medical help by calling 9-1-1. Otherwise, do not stop taking your pregabalin medication without first speaking with your healthcare professional or pharmacist, as stopping suddenly may cause withdrawal symptoms including insomnia, nausea, headache, anxiety, excessive sweating, diarrhea, and convulsions.Return the product to the pharmacy where it was purchased as soon as possible for a replacement or alternative supply, and for proper disposal. If you are unsure whether your product is recalled, check with your pharmacy.Seek medical attention if you have used this product and think you are experiencing side effects.Contact Teva Canada Customer Care by calling toll-free at 1-800-268-4129 or by email at [email protected], if you have questions about this recall.Report any health product-related side effects or complaints to Health Canada.
Evidence AMHRASignal Med · T2💊 Small moleculeRecall
MHRA issued a Class 4 Medicines Defect Notification after Martindale Pharmaceuticals Ltd reported an error with the linear barcode on some batches of Clobazam oral suspension.
Published
2026-09-17
Document no.
df8ca708060a
Class
Class 4
Companies
Martindale Pharmaceuticals Ltd
Original text and translation
Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.
Key facts · Basis: official source record kept by the collector
Class: Class 4 Medicines Defect Notification
Reason: an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL
Reference: EL(26)A/38
Insight · Editorial insight
Class 4 is the tier that circulates caution rather than removing stock, and here the defect is in identification data. A barcode is how the product is identified at dispensing and administration, so a misread risk remains even with sound contents, and packaging control has to reach past printed text into machine-readable data.
Check points
Verification procedure for barcodes and other machine-readable data on packaging
Whether barcodes are re-verified when packaging artwork changes
Recall detail · From the source · MHRA
Full alert (Drug Alert)
Original · MHRA
DMRC reference number DMRC- 40754020 Marketing Authorisation Holder Martindale Pharmaceuticals Ltd Medicine Details Clobazam Martindale Pharma 5 mg/5 mL Oral Suspension 150ml PL: 00156/0322 Active ingredient: clobazam SNOMED code: 42289011000001100 GTIN: 5014124144224 Affected Lot Batch Numbers Batch No. Expiry Date Pack Size First Distributed 0162858 05/2028 1 18/08/2026 0163605 07/2028 1 14/09/2026 Medicine Details Clobazam Martindale Pharma 10 mg/5 mL Oral Suspension 150ml PL: 00156/0323 Active ingredient: clobazam SNOMED code: 42289711000001100 GTIN: 5014124144231 Affected Lot Batch Numbers Batch No. Expiry Date Pack Size First Distributed 0163858 07/2028 1 14/09/2026 Background Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL. The above batches were packaged in cartons containing an incorrect pre-printed linear barcode. The linear barcode present represents the GTIN for the branded version of the product (Tapclob). It should instead reflect the generic name: Clobazam. The code in the 2D printed barcode is correct. Example for 5mg/5mL 150mL pack: The associated strength and bottle size documented on the pre-printed package remain correct and unchanged. Full batch quantities: Batch 0162858: 5,544 units Batch 0163605: 2,277 units Batch 0163858: 4,631 units Future batches of Clobazam for both strengths and pack size will have the barcode corrected via the application of a sticker until new cartons are available to maintain supply for patients. Advice for Healthcare Professionals: There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to note the above-mentioned batches of Clobazam Oral Suspension and use the serialized 2D barcode for authentication and traceability, as it remains accurate. The linear barcode on the carton should not be used for product identification. Additional precautions should be considered by wholesalers and pharmacies using the linear barcode in a wholesale facility. Advice for Patients: This notification relates to a barcode error on the outer packaging of the product. The medicine itself is not affected, and patients do not need to take any action. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme . Additional information: For further information, medical enquiries and stock information, contact: [email protected] Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 [email protected] Download document Class 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada recalled affected lots of Platinum Naturals Easymulti Stress (Men) capsules over a labelling error. The recall is classified Type III.
Published
2026-09-16
Document no.
hc-82628
Companies
Platinum Naturals Ltd.
Product
Easymulti Stress (Men) capsules
Class
Type III
Original text and translation
Labelling
Key facts · Basis: official source record kept by the collector
Recall class: Type III, category Natural health products
Issue: Labelling, described in the recall title as affected lots incorrectly labelled for Vitamin B6 quantity
Product: Easymulti Stress (Men) capsules, multiple vitamins and minerals, capsule form
What you should do: verify if your product is affected
Insight · Editorial insight
The recall turns on a declared content figure diverging from the actual one, not on the contents themselves. Multi-ingredient products carry as many label figures as ingredients, so a single wrong number slips proofing easily, and what matters is whether label content is reconciled against formula content as a step of its own.
Check points
Reconciliation of declared label content against formula content for multi-ingredient products
Records confirming packaging artwork updates when an ingredient figure changes
Recall detail · From the source · Health Canada
Active ingredient · multiple vitamins and mineralsDosage form · Capsule
What you should do
Original · Health Canada
Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for 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.
[Recall (Health Canada) · Health Canada]Organika — Site not on licence recall
Evidence AHealth CanadaSignal Med · T2Recall
Health Canada recalled three Organika gummy products over an establishment and site licensing issue. The recall is classified Type III.
Published
2026-09-15
Document no.
hc-82618
Companies
Organika
Product
Organika® Lion's Mane Gummies; Organika® Reishi Gummies; Organika® Creatine Gumm…
Class
Type III
Original text and translation
Establishment/Site licensing
Key facts · Basis: official source record kept by the collector
Recall class: Type III, category Natural health products
Issue: Establishment/Site licensing, described in the recall title as a foreign site not listed on the site licence
Products: Organika Lion's Mane Gummies, Organika Reishi Gummies and Organika Creatine Gummies, gummy form
What you should do: verify if your product is affected
Insight · Editorial insight
The recall stems from an authorisation gap - a manufacturing site not listed on the licence - rather than from a product defect. When adding or changing a contract site, a licence listing that lags behind the start of production leaves product with no quality issue having to be pulled from the market.
Check points
Sequencing of licence listing completion against production start when adding or changing a contract site
Periodic reconciliation of licensed site listings, including foreign sites
Recall detail · From the source · Health Canada
Active ingredient · 2000 mgDosage form · Gummy
What you should do
Original · Health Canada
Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product, or for 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.
[Recall (Health Canada) · Health Canada][HC] Generic acetaminophen by Teva recalled because it may c… — Foreign material Type I recall
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada recalled Novo-Gesic Forte 500 mg tablets (acetaminophen) because the product may contain foreign material. The recall is classified Type I.
Published
2026-09-10
Document no.
hc-82615
Companies
미확인
Product
Novo-Gesic Forte 500 mg tablets (acetaminophen)
Class
Type I
Original text and translation
Contamination - Product quality
Key facts · Basis: official source record kept by the collector
Recall class: Type I, category Drugs
Issue: Contamination - Product quality, described in the recall title as possible foreign material
Product: Novo-Gesic Forte 500 mg tablets (acetaminophen)
What you should do: immediately stop using the affected product and return it to your local pharmacy for replacement and proper disposal
Insight · Editorial insight
Possible foreign material in a widely used analgesic was enough for a top-tier recall. Foreign matter can enter from raw materials, equipment wear or packaging, so no single process check narrows the cause; where detection sits on the line - metal detection, visual inspection - is what decides the size of the recall.
Check points
Placement and detection limits of foreign matter detection on solid dosage lines
Batch traceability procedure triggered by a foreign matter complaint
Recall detail · From the source · Health Canada
What you should do
Original · Health Canada
Immediately stop using the affected product and return it to your local pharmacy for replacement and proper disposal. If you are unsure whether your product is recalled, check with your pharmacy.Consult your healthcare practitioner if you have used the affected product and have concerns about your health.Contact Teva Canada Customer Care by calling toll-free at 1-800-268-4129 or by email at [email protected], if you have questions about this recall.Report any health product-related side effects or complaints to Health Canada.
Evidence AFDASignal Med · T2💊 Small moleculeRecall
Baxter Healthcare Corporation recalled Vancomycin Injection, USP in 5% Dextrose in GALAXY Single-Dose Containers over CGMP deviations. Seventeen products were recalled together for the same reason.
Published
2026-09-09
Document no.
D-0805-2026
Companies
Baxter Healthcare Corporation
Product
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48. 외 16품목
Class
Class II
All 17 products
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
Original text and translation · representative case
CGMP Deviations
Key facts · Basis: official source record kept by the collector
Class: Class II
Reason: CGMP Deviations
Scope: 17 products recalled together for the same reason
Product: Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, among others
Insight · Editorial insight
The recall rests on a manufacturing system deviation rather than a test result. When a CGMP deviation rather than a specification failure triggers a recall, the scope tends to take in whole batches made during the affected period, which is the same logic under which 17 products moved together here.
Check points
Procedure for determining the affected batch range when a CGMP deviation occurs
Deviation notification clauses in contracts with sterile injectable suppliers
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 17 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 · 2026-08-06FDA classification · 2026-08-28FDA published · 2026-09-09
Affected lots and expiry
Original · OpenFDA
Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.
Recall size and scope
Distribution — US Nationwide; Puerto Rico; and Chile.
[Recall · FDA]Allies Group Inc. — Subpotent SPF recall
Evidence AFDASignal Med · T2Recall
Allies Group Inc. recalled an SPF 50 sunscreen gel product as subpotent. Four products were recalled together for the same reason.
Published
2026-09-09
Document no.
D-0823-2026
Companies
Allies Group Inc.
Product
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224 외 3품목
Class
Class II
All 4 products
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
Original text and translation · representative case
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Key facts · Basis: official source record kept by the collector
Class: Class II
Reason: Subpotent Product - firm testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label
Scope: four products recalled together for the same reason
Product: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%)
Insight · Editorial insight
The firm's own testing showing the product may not deliver its labelled performance is what drove the recall. Where a declared performance level is underwritten by testing, the question is whether that level holds across the whole shelf life; conformity at release alone does not complete the case.
Check points
Data showing the declared performance level holds across the full shelf life
Decision procedure for initiating a recall when the firm's own testing finds an out-of-specification result
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 4 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 · 2026-08-14FDA classification · 2026-08-31FDA published · 2026-09-09
[Recall · FDA]Lexia LLC Broadway Joe's Pain Cream, (Histamine Dihydrochlor… — Raw material contamination recall
Evidence AFDASignal Med · T2Recall
Lexia LLC recalled a topical pain cream product over CGMP deviations involving potential contamination of raw material. Two products were recalled together for the same reason.
Original text and translation · representative case
CGMP Deviations: Potential contamination of raw material
Key facts · Basis: official source record kept by the collector
Class: Class II
Reason: CGMP Deviations: Potential contamination of raw material
Scope: two products recalled together for the same reason
Product: Broadway Joe's Pain Cream (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz jar
Insight · Editorial insight
What is cited is possible contamination in an incoming material, not a finished-product result. Risk at the material stage does not necessarily show up in finished-product testing, which leaves supplier qualification and the scope of incoming material testing as the working line of defence.
Check points
Whether contamination risk attributes are covered in supplier qualification
Whether incoming material testing would detect the contamination types expected
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 2 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 · 2026-08-21FDA classification · 2026-09-02FDA published · 2026-09-09
Key facts · Basis: official source record kept by the collector
Class: Class II
Reason: Failed Dissolution Specifications
Product: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial
Insight · Editorial insight
A specification failure in an immunosuppressant is what gives this recall its weight, since the attribute sits close to efficacy for this class. Dissolution failures can originate in material properties or in process variables, so closing one out by discarding the batch without establishing the cause is the pattern that returns.
Check points
Scope of root cause investigation for a dissolution failure, covering material properties and process variables
Dissolution control strategy for narrow therapeutic index products such as immunosuppressants
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-08-26FDA classification · 2026-09-03FDA published · 2026-09-09
Affected lots and expiry
Original · OpenFDA
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
A dissolution failure in an extended-release product points at the release-controlling structure not behaving as designed. Coatings and matrices that control release are sensitive to process variables, so in-process controls have to tie to the dissolution result more tightly here than for a conventional tablet.
Check points
Linkage between release-controlling elements and in-process controls for extended-release products
Management of dissolution specifications across the sampling time points for extended-release products
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiated
Status
Recall initiated · 2026-08-31FDA classification · 2026-09-03FDA published · 2026-09-09
Tablets or capsules from another product ended up in the pack, which is a breakdown in mix-up prevention rather than in product quality. Mix-ups arise where line clearance and product changeover checks on the packaging line are performed as a formality, and because finished-product testing does not detect them, they often surface only at the consumer.
Check points
Line clearance records at product changeover on packaging lines
Mix-up prevention devices and inspection points in the packaging process
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-08-24FDA classification · 2026-09-08FDA published · 2026-09-09
Card titles, summaries, Korean translations, implications, check items, and detailed analysis are content generated automatically by generative AI from published primary official material.
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3. Verification, limitations, and user notes
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