Global Regulatory Monitor Regulatory News, Week 1 · 2026/9
Period 2026-08-31 ~ 2026-09-07Published 2026-09-07Collected 85 · 33 cardsEvidence A 25 · B 8 · C 0
19 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 Class I recall of a compounded glutathione injection from Victory Medical Center Pharmacy over out-of-specification bacterial endotoxin results
Two more FDA Class I recalls: particulate matter in Optiray contrast injection and undeclared drug ingredients in Kian Pee Wan capsules
MFDS suspends manufacturing of nine products at one company for failing to carry out ordered testing, with three months imposed on the two repeat violations
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.
[FDA 483 observation · FDA]Fayetteville VA Medical Center — Aseptic area contamination and cross-contamination
Evidence BFDASignal High · T3💊 Small molecule483
FDA recorded Form 483 observations at Fayetteville VA Medical Center, a producer of sterile drug products, covering microbial contamination on ISO Class 5 surfaces and inadequate control of beta-lactam cross-contamination.
Published
2026-09-03
Document no.
fda483-194570
Site / company
Fayetteville VA Medical Center · FEI 1073803
Site · type
Producer of Sterile Drug Products · 483
Inspection date
06/15/2026
Key facts · Basis: official index plus supporting sources
Observation 1: surface samples in the ISO Class 5 area recovered 4 cfu/plate above the action level, with no investigation or corrective plan performed
Observation 3: beta-lactam and non-beta-lactam products compounded in the same ISO Class 5 area with inadequate cross-contamination controls
Site and type: Producer of Sterile Drug Products, Form 483 (FEI 1073803)
Inspection date: 06/15/2026
Insight · Editorial insight
An environmental monitoring excursion left uninvestigated and weak beta-lactam segregation were cited in the same inspection. Sterile manufacturing and compounding sites should review how surface monitoring action-level excursions are handled procedurally, together with their beta-lactam cross-contamination controls.
Check points
Procedure for investigating and correcting surface environmental monitoring action-level excursions
Dedicated equipment and area segregation and cleaning standards for beta-lactam products
Effectiveness of cleaning and disinfection records for aseptic compounding equipment
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Observation detail · 3 observations · From the source
Inspectors: Erik W Koester · Syeda N Mahazabin
Observation 1
Microbial contamination was present in the.
Specifically, On 05/08/2025, a surface sample collected from <Redacted B4> (S/N: <Redacted B4>), an ISO Class 5 used for the production of sterile drug products, yielded 4 cfu/plate, exceeding the action limit of <Redacted B4> cfu/plate. The sample was classified as Out of Compliance (OOC) and the following organisms were identified: Cladosporium spp. (pathogenic), Corynebacterium tuberculostearicum, Staphylococcus saprophyticus L and Fungal Overgrowth. Per email documentation provided by the firm, the <Redacted B4> (S/N; <Redacted B4>) was not used following the OOC result until passing recertification, which occurred approximately <Redacted B4> later. Your firm failed to investigate the cause of the OOC result and implement a corrective action plan as required by your Policy Number 797-2022, entitled, Microbiological Air and Surface Monitoring Program, version 2. Additionally, your firm was unable to demonstrate that the 6R4 was not used for the production of sterile drug products during this period.
Observation 2
Fairlue to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
Observation 3
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
Specifically, • The firm has routinely reduced both Beta-lactam and non-Beta-lactam drug products within the same ISO 5 <Redacted B4>. S/N: <Redacted B4> and (S/N: <Redacted B4>). During this time the firm's procedure "Cleaning and Disinfecting Compounding Areas" only require the operator to apply sterile <Redacted B4> to surfaces <Redacted B4> production. For example, the firm produced Piperacillin Tazobactam 4.5g7vial Injection; Sodium Chloride 0.9% Injection Bag Bag 100ml on 05/28/2026. The firm failed to conduct decontamination of the <Redacted B4> then produced Phosphorus 3mmol/Potassium 4.4 Meq/ml Injection; Sodium Chloride 0.9% Injection Bag 250ml. • On 06/09/2026, we observed production within 1SO-5 <Redacted B4>) S/N: <Redacted B4>. We then observed that the technician only applied <Redacted B4> to the <Redacted B4> of the <Redacted B4> and no on other surfaces. The firm's current unofficial clearing procedure allows operators to only apply <Redacted B4> to the <Redacted B4> following the production of any Beta Lactam products.
[Warning Letter · FDA]PReye, LLC — Aseptic area design and quality unit failures
Evidence BFDASignal High · T3💊 Small moleculeCGMP
FDA issued a warning letter to PReye, LLC citing inadequate separation and design of aseptic processing areas and a quality control unit that did not carry out its responsibilities.
Published
2026-09-01
Document no.
19999bb2b8a8
Company / site
PReye, LLC
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 08/18/2026
Key facts · Basis: official index plus supporting sources
Citation 1: failure to provide adequate separation and equipment design in aseptic processing areas to prevent contamination and mix-ups (21 CFR 211.42(c)(10), 21 CFR 211.63)
Citation 2: quality control unit failed to assure conformance to identity, strength, quality and purity specifications (21 CFR 211.22)
Issuing office and date: Center for Drug Evaluation and Research (CDER), 08/18/2026
Insight · Editorial insight
FDA treated the physical design of aseptic areas and the quality unit's ultimate accountability as one matter. Aseptic sites should be able to show qualification evidence for area separation and equipment layout alongside documented quality unit authority over specification conformance decisions.
Check points
Qualification evidence for aseptic area separation and equipment layout
Documented quality control unit responsibilities and specification conformance records
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Violation detail · 2 items · From the source
Violation 121 CFR 211.42(c)(10) · 21 CFR 211.63
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. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.42(c)(10) and 21 CFR 211.63).
Violation 221 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]Fresenius Medical Care AG & Co. KGaA — Deviation investigation and process control gaps
Evidence BFDASignal High · T3💊 Small moleculeCGMP
FDA issued a warning letter to Fresenius Medical Care AG & Co. KGaA citing failure to investigate batch specification failures and the absence of written manufacturing and process control procedures.
Published
2026-09-01
Document no.
a9cbe135c72a
Company / site
Fresenius Medical Care AG & Co. KGaA
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 08/25/2026
Key facts · Basis: official index plus supporting sources
Citation 1: failure to thoroughly investigate unexplained discrepancies and batch specification failures, including batches already distributed (21 CFR 211.192)
Citation 2: failure to establish written production and process control procedures designed to assure identity, strength, quality and purity (21 CFR 211.100(a))
Issuing office and date: Center for Drug Evaluation and Research (CDER), 08/25/2026
Insight · Editorial insight
The depth of specification-failure investigations and the process controls that should follow from them were required as a single package. Quality assurance functions should be able to trace whether the conclusions of deviation and OOS investigations actually resulted in revised production and process control procedures.
Check points
Scope of OOS and deviation investigations and the basis for root cause determinations
History of investigation outcomes being reflected in production and process control procedures
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Violation detail · 2 items · From the source
Violation 121 CFR 211.192
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
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)).
[Warning Letter · FDA]Reliance Life Sciences Private Limited — Incomplete test records and aseptic validation
Evidence BFDASignal High · T3💊 Small moleculeCGMP
FDA issued a warning letter to Reliance Life Sciences Private Limited in India citing incomplete laboratory records and inadequate procedures and validation for preventing microbiological contamination in aseptic processing.
Published
2026-09-01
Document no.
e0c0ffd7230c
Company / site
Reliance Life Sciences Private Limited
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 08/18/2026
Key facts · Basis: official index plus supporting sources
Citation 1: laboratory records did not include complete data derived from all tests necessary to assure compliance with specifications and standards (21 CFR 211.194(a))
Citation 2: failure to establish and follow written procedures to prevent microbiological contamination of products purporting to be sterile, and failure to validate aseptic and sterilization processes (21 CFR 211.113(b))
Issuing office and date: Center for Drug Evaluation and Research (CDER), 08/18/2026
Insight · Editorial insight
Incomplete laboratory records were cited alongside a reliability problem in aseptic process validation. Sterile product sites should check that the scope of retained raw test data is consistent with the evidence supporting their aseptic and sterilization process validation.
Check points
Completeness of raw laboratory data and the extent of audit trail coverage
Evidence supporting aseptic and sterilization process validation and revalidation
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Violation detail · 2 items · From the source
Violation 121 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 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)).
[Warning Letter · FDA]Jabil Inc. — Investigations, aseptic process, facility upkeep
Evidence BFDASignal High · T3💊 Small moleculeCGMP
FDA issued a warning letter covering the Pharmaceutics International, Inc. site of Jabil Inc., citing inadequate deviation investigations, missing quality unit procedures, failures in aseptic contamination control, and poor building maintenance.
Published
2026-09-01
Document no.
fda468f6708d
Company / site
Jabil Inc.
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 08/27/2026
Key facts · Basis: official index plus supporting sources
Citation 1: failure to thoroughly investigate unexplained discrepancies and batch specification failures (21 CFR 211.192)
Citation 2: failure to establish written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d))
Citation 3: failure in aseptic contamination control procedures and validation, and buildings not maintained in a good state of repair (21 CFR 211.113(b), 21 CFR 211.58)
Issuing office and date: Center for Drug Evaluation and Research (CDER), 08/27/2026
Insight · Editorial insight
Deviation investigations, quality unit procedures, aseptic processing and building maintenance were cited in one letter and treated as a quality system level defect. Companies relying on contract manufacturing should extend audit scope beyond aseptic process validation to the physical condition and maintenance of buildings and equipment.
Check points
Deviation closure criteria and quality unit approval records at contract manufacturing sites
Maintenance and repair history for aseptic manufacturing buildings and equipment
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Violation detail · 3 items · From the source
Violation 121 CFR 211.192
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Violation 221 CFR 211.22(d)
Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
Violation 321 CFR 211.113(b) · 21 CFR 211.58
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. Your firm also failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.113(b) and 21 CFR 211.58).
[Warning Letter · FDA]Shoolin Pharma Chem LLP — Insanitary API site and cleaning control gaps
Evidence BFDASignal High · T3▫️ OtherCGMP
FDA issued a warning letter to Shoolin Pharma Chem LLP in India, an active pharmaceutical ingredient manufacturer, citing insanitary manufacturing conditions and inadequate control of cleaning and laboratory records.
Published
2026-09-01
Document no.
76bb92bc7f71
Company / site
Shoolin Pharma Chem LLP
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 08/18/2026
Key facts · Basis: official index plus supporting sources
Citation: insanitary conditions including residue and corrosion on non-dedicated equipment and inadequate gowning in open processing areas
Citation: no written cleaning and maintenance procedures established, and cleaning not verified through swab or rinse testing
Citation: insufficient evidence that tests reported on certificates of analysis were performed, and contract laboratory results issued as the firm's own certificates without naming the performing laboratory
Issuing office and date: Center for Drug Evaluation and Research (CDER), 08/18/2026
Insight · Editorial insight
At an API site supplying the United States for compounding use, cleaning and laboratory record deficiencies escalated into a finding of insanitary conditions. Finished product manufacturers should strengthen the cleaning validation evidence and raw data checks they require when auditing API suppliers.
Check points
Cleaning validation evidence for non-dedicated equipment at API suppliers
Identification of the performing laboratory for contract testing and procedures for verifying raw data
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[WHO · WHO]SCL Lifesciences (API Corp - formerly Saurav) — API site found compliant with WHO GMP
Evidence BWHOSignal Med · T2WHO
WHO published the inspection report for the SCL Lifesciences (API Corp - formerly Saurav) active pharmaceutical ingredient site in India, assessing it as operating at an acceptable level of compliance with WHO API GMP guidelines.
Inspection date
2026-03-16
Document no.
who-whopir-443308706477
Topic
SCL Lifesciences (API Corp - formerly Saurav)
Issuing authority
WHO
Key facts · Basis: official index plus supporting sources
Outcome: assessed as operating at an acceptable level of compliance with WHO API GMP guidelines
Follow-up: non-compliances identified during the inspection were addressed to a satisfactory level before the report was published
Validity: valid for three years provided inspections carried out during that period are positive
Inspection date: 2026-03-16
Insight · Editorial insight
WHO inspection reports publish observations by area, covering quality management, laboratory and validation, not just the overall outcome, which makes them usable as supplier assessment material. Manufacturers evaluating overseas API suppliers can compare the area-by-area content of a WHOPIR against their own audit findings.
Check points
Whether a WHOPIR is published for the API supplier and its validity period
Comparison of area-by-area WHOPIR content against internal supplier audit results
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Administrative action · MFDS]미래바이오제약(주) — Manufacturing suspension for unperformed testing
Evidence AMFDSSignal High · T3💊 Small moleculeAdministrative action
The Ministry of Food and Drug Safety confirmed that a manufacturer did not carry out testing ordered by the regional office, or did not submit the results, and suspended manufacturing of the affected products.
○ 경인지방식품의약품안전청장의 시험검사 명령에 따라 식품의약품안전처장이 지정하는 의약품 등 시험·검사기관에서 의약품을 검사한 후 그 결과를 제출하여야 함에도 불구하고, ‘노텍정(세티리진염산염)’ 등 9품목*에 대하여 시험검사를 실시하지 않거나 그 결과를 제출하지 않은 사실이 있음
* (1차 위반) 노텍정(세티리진염산염), 하이타민골드정, 탄시나정, 하이드로핀정(펠로디핀), 헤파코엔정, 싸이베린정, 멀티브큐골드정
* (2차 위반…
Key facts · Basis: Intake raw
Grounds: failure to comply with an order to have products tested at a designated testing institution and submit the results, covering nine products including a cetirizine hydrochloride tablet
Breakdown: seven products at first violation and two products at second violation
Action: manufacturing suspension of one month for the affected products, with the period varying by product, and three months for the two repeat products (September 16, 2026 to December 15, 2026)
Published: 2026-09-02
Insight · Editorial insight
The action confirms an escalation structure in which repeated failure to comply with a testing order raises the suspension from one month to three. Quality assurance functions should confirm they have a control point that tracks receipt, execution and result submission for regulator-ordered testing, together with the applicable deadlines.
Check points
System for tracking receipt, execution and result submission of regulator-ordered testing
Review frequency for compliance, given the heavier penalty applied to repeat violations
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Administrative action · MFDS]동광제약(주) — Batch record reissue procedure not followed
Evidence AMFDSSignal High · T3💊 Small moleculeAdministrative action
The Ministry of Food and Drug Safety confirmed that a manufacturer rewrote records without following the reissue procedure set out in its own standards for manufacturing and packaging instructions and records, and suspended manufacturing.
○ 의약품 제조업자는 의약품을 제조하면서 제조관리기준서, 제품표준서 등에 따라 정확히 제조하여야 하고, 작성된 기준서 및 지시서를 준수하여야 함
- 의약품 ‘싸이원주(싸이모신알파1)’, ‘동광로수바스타틴칼슘정20mg’을 제조·판매함에 있어 자사 기준서 일반 SOP ｢제조(포장)지시 및 기록서 작성 및 관리(문서번호 GS-DC02-02, 승인일자 2024.3.26.)｣의 4.
Key facts · Basis: Intake raw
Grounds: manufacturing instructions and records reissued without a completed and approved reissue request, with output, receipt quantity and yield rewritten and the superseded documents neither retrieved nor destroyed
Products: a thymosin alpha 1 injection, a rosuvastatin calcium 20 mg tablet, and a contract-manufactured capsule product
Action: one month manufacturing suspension for the affected products (September 15, 2026 to October 14, 2026) and 15 days for the affected dosage form, capsules (September 15, 2026 to September 29, 2026)
Published: 2026-09-01
Insight · Editorial insight
A failure to control record reissue led directly to output and yield figures being rewritten, making this a data integrity matter. Quality assurance functions should verify that all three steps, requesting reissue, approving it, and destroying the superseded document, leave an actual record.
Check points
Retention of reissue request and approval records for manufacturing and packaging instructions and records
Evidence of retrieval and destruction of superseded documents on reissue
Compliance with site standards for contract-manufactured products
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[GMP inspection · MFDS](주)코아팜바이오 — GMP findings across six inspection areas
Evidence AMFDSSignal High · T3💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety published the result of a post-approval GMP inspection of a finished product site, with deficiencies identified across six areas: quality management, premises and equipment, manufacturing, laboratory, materials, and packaging and labelling.
Published
2026-09-01
Document no.
gmpinspect-1Q1QIYZZKMK
Site
(주)코아팜바이오
Inspection period
2026-04-27~2026-04-29
Original text
평가 결과 지적(보완)사항(Deficiencies) 1) GMP 감시 분야(6개): 품질경영, 시설장비, 제조, 시험실, 원자재, 포장표시 2) 지적사항은 PIC/S 정의에 따라 중대, 중요, 기타로 구분됨 - 지적사항 중 ‘중대･중요’ 건은 행정처분 부과, ‘기타’ 건은 시정·보완토록 함 - 행정처분 부과가 확정되면 ‘의약품안전나라 행정처분정보’를 통해 공개됨 - ‘중대･중요’ 지적사항은 보완 완료 후, ‘기타’ 지적사항은 이행계획의 타당성이…
Key facts · Basis: Intake raw
Areas cited: quality management, premises and equipment, manufacturing, laboratory, materials, and packaging and labelling
Classification: deficiencies are graded critical, major or other under PIC/S definitions, with critical and major findings subject to administrative action
Inspection period: 2026-04-27 to 2026-04-29
Published: 2026-09-01
Insight · Editorial insight
When findings are spread across all six inspection areas, correcting individual items rarely explains the pattern and a quality system level diagnosis usually follows. Sites should check whether recent inspections produced findings spread widely across areas, and whether common causes across those areas have been documented.
Check points
Common root cause analysis across deficiencies in different inspection areas
Whether classification as critical or major implies follow-on administrative action
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[GMP inspection · MFDS]한국원자력연구원 — Quality assurance system and data integrity
Evidence AMFDSSignal Med · T2💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety published the result of a post-approval GMP inspection, with findings in the quality management area concerning operation of the quality assurance system and data integrity.
Published
2026-09-04
Document no.
gmpinspect-1Q1fl7wKsOT
Site
한국원자력연구원
Inspection period
2026-05-06~2026-05-08
Original text
평가 결과: 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약3) 비고3) 품질경영 기타 [별표 1] 1의2 [별표 1의2] 2 품질 목표 달성을 위하여 의약품 제조업의 경영진과 작업원은 품질 보증시스템을 마련하고, 적절하게 시행할 것 이행계획서 타당성 인정 품질경영 기타 [별표 1] 3.1 데이터 완전성 관련 지침을 운영 할 전담 조직을 구성할 것 이행계획서 타당성 인정 품질경영 기타 [별표 1] 3.
Key facts · Basis: Intake raw
Finding: management and personnel shall establish and properly implement a quality assurance system to meet quality objectives
Finding: a dedicated organisation shall be formed to operate data integrity guidance
Classification: all graded other, with the corrective action plan accepted as reasonable
Inspection period: 2026-05-06 to 2026-05-08
Insight · Editorial insight
The inspection looked beyond having data integrity guidance on paper to whether an organisation exists to operate it. Sites should confirm that an organisation and defined roles are assigned to execute and monitor the data integrity policy.
Check points
Whether a dedicated organisation and roles are assigned to operate data integrity guidance
Level of documentation evidencing operation of the quality assurance system
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[GMP inspection · MFDS]동성제약(주) — Equipment calibration and purified water
Evidence AMFDSSignal Med · T2💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety published the result of a post-approval GMP inspection of a finished product site, with findings in the premises and equipment area concerning equipment calibration and purified water system control.
Published
2026-09-04
Document no.
gmpinspect-1Q1fmUkaKmS
Site
동성제약(주)
Inspection period
2026-01-27~2026-01-30
Original text
평가 결과: 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약3) 비고3) 시설장비 기타 [별표 1] 2.1 제조에 사용되는 중요 기계·설비에 대하여 모든 중요공정변수를 포함 하여 교정할 것 이행계획서 타당성 인정 시설장비 기타 [별표 1] 2.1 칭량작업에 사용하는 저울의 실제 사용 범위를 고려하여 일일점검을 수행할 것 이행계획서 타당성 인정 시설장비 기타 [별표 1] 2.
Key facts · Basis: Intake raw
Finding: critical machinery and equipment used in manufacturing shall be calibrated covering all critical process parameters
Finding: daily checks of balances used for weighing shall be performed considering the actual range of use
Finding: the suitability of filters in the purified water system shall be verified periodically
Classification: graded other, with the corrective action plan accepted as reasonable
Insight · Editorial insight
Routine control items such as calibration, daily checks and water filters are being re-examined against the standards of critical process parameters and actual range of use. Sites should confirm that calibration ranges and balance check ranges numerically cover real operating conditions.
Check points
Whether calibration ranges for critical equipment cover all critical process parameters
Alignment between the daily balance check range and the actual weighing range
Frequency of purified water system filter suitability verification
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[GMP inspection · MFDS]유니메드제약(주) — Equipment qualification and labelling checks
Evidence AMFDSSignal Med · T2💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety published the result of a post-approval GMP inspection, with findings on calibration and qualification of premises and equipment and on inspection procedures in the packaging and labelling area.
Published
2026-09-03
Document no.
gmpinspect-1Q1aXrIaooX
Site
유니메드제약(주)
Inspection period
2026-03-09~2026-03-12
Original text
평가 결과: 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약3) 비고 시설장비 기타 [별표 1의2] 5 제조 및 시험에 사용하는 중요 장비의 교정을 실시할 것 보완 완료 기타 장비의 가동범위을 모두 포함하여 적격성평가를 실시할 것 이행계획서 타당성 인정 포장표시 기타 [별표 1의2] 9 표시재료 사용 전 점검절차를 마련할 것 이행계획서 타당성 인정 제조 기타 [별표 1의2] 12.
Key facts · Basis: Intake raw
Finding: critical equipment used in manufacturing and testing shall be calibrated, closed as corrected
Finding: qualification shall be performed covering the full operating range of equipment, with the corrective action plan accepted as reasonable
Finding: a procedure shall be established for checking labelling materials before use
Inspection period: 2026-03-09 to 2026-03-12
Insight · Editorial insight
A finding requiring qualification across the full equipment operating range appeared together with one on pre-use checks of labelling materials, putting both equipment and packaging operations under review. Sites should check that qualification reports cover all actual operating conditions and that pre-use checks of labelling materials are documented.
Check points
Alignment between the scope of equipment qualification and the actual operating range
Whether a pre-use check procedure for labelling materials is established and recorded
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[GMP inspection · MFDS]경방신약(주) — Record retention and cleaning validation
Evidence AMFDSSignal Med · T2💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety published the result of a post-approval GMP inspection, with findings concerning retention of records from automated systems and cleaning validation of production equipment.
Published
2026-09-03
Document no.
gmpinspect-1Q1ah2GeC5e
Site
경방신약(주)
Inspection period
2026-04-13~2026-04-16
Original text
평가 결과: 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약3) 비고 시설장비 기타 [별표 1] 2.2 자동화장치 등 모든 기록은 저장 및 보관할 것 이행계획서 타당성 인정 기타 [별표 1의2] 5 장비의 가동범위을 모두 포함하여 적격성평가를 실시할 것 보완완료 기타 생산 설비에 대한 세척 밸리데이션을 실시할 것 이행계획서 타당성 인정 제조 기타 [별표 1] 6.4 [별표 1의2] 12.
Key facts · Basis: Intake raw
Finding: all records, including those produced by automated systems, shall be stored and retained
Finding: qualification shall be performed covering the full operating range of equipment, closed as corrected
Finding: cleaning validation shall be performed for production equipment, with the corrective action plan accepted as reasonable
Inspection period: 2026-04-13 to 2026-04-16
Insight · Editorial insight
Retention of automated system records, which bears on data integrity, and cleaning validation of production equipment, which bears on cross-contamination control, were cited in the same inspection. Sites should confirm the storage location and retention period for electronic records from automated equipment and that the list of equipment subject to cleaning validation is current.
Check points
Storage path and retention period configured for electronic records from automated systems
List of equipment subject to cleaning validation and the record of validation performed
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[GMP inspection · MFDS](주)이든파마 — Compressed air control and cleaning validation
Evidence AMFDSSignal Med · T2💊 Small moleculeGMP inspection
The Ministry of Food and Drug Safety published the result of a post-approval GMP inspection, with findings concerning quality control of compressed air in direct contact with drug products and cleaning validation.
Published
2026-09-01
Document no.
gmpinspect-1Q1QIYZZLwM
Site
(주)이든파마
Inspection period
2026-05-27~2026-05-29
Original text
평가 결과 지적(보완)사항(Deficiencies) 분야1) 구분2) 근거 법령 지적(보완)사항 요약 비고3) 시설장비 기타 [별표 1] 2.1 의약품과 직접 접촉하는 압축공기에 대하여 적절한 품질관리 시스템을 갖출 것 이행계획서 타당성 인정 제조 기타 [별표 1] 6.4 제품과 접촉하는 설비에 대해 세척밸리데이션을 실시할 것 이행계획서 타당성 인정 기타 [별표 1] 6.
Key facts · Basis: Intake raw
Finding: an appropriate quality control system shall be in place for compressed air in direct contact with drug products
Finding: cleaning validation shall be performed for equipment in contact with product
Finding: cleaning validation shall be performed for campaign production
Inspection period: 2026-05-27 to 2026-05-29
Insight · Editorial insight
Compressed air as a product-contact utility and cleaning after campaign production were cited as separate items, extending cross-contamination control beyond equipment itself. Sites should confirm the specifications and monitoring basis for product-contact utilities such as compressed air, and the cleaning verification evidence at the end of a campaign.
Check points
Whether specifications and monitoring criteria are established for product-contact compressed air
Cleaning validation evidence at the end of campaign production
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Guidance · MFDS]의약품 품목별 사전 GMP 평가 업무수행 편람 — Manual on pre-approval GMP assessment
Evidence BMFDSSignal Med · T2Guidance
The Ministry of Food and Drug Safety published a working manual on product-level pre-approval GMP assessment. The document has no official English title, so it is described here rather than named.
Published
2026-08-31
Document no.
data0010-15291
Issuing authority
MFDS
Topic
의약품 품목별 사전 GMP 평가 업무수행 편람
Key facts · Basis: official index plus supporting sources
Issuing body: Ministry of Food and Drug Safety, published 2026-08-31
Subject: how product-level pre-approval GMP assessment is carried out
Detail: not available, the source document needs to be consulted
Insight · Editorial insight
Setting out the working standards for product-level pre-approval GMP assessment in a manual makes the reviewer's perspective visible in a document. Regulatory affairs and quality assurance functions should compare their pre-approval GMP submission material against the structure of the source document.
Check points
Comparison of the submission package for product-level pre-approval GMP assessment
Nonconformity in assay and pH, both basic specification attributes, points to control at the release testing decision stage. Quality assurance functions should review the acceptance criteria for assay and pH in comparable dosage forms and the procedure for reviewing test results before release.
Check points
Appropriateness of acceptance criteria and test methods for assay and pH
Records of review and approval of test results before release
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
A recall and sales suspension was ordered for a disinfectant ethanol product on the ground of quality nonconformity in assay.
Published
2026-09-02
Document no.
recall-7f469a289a34
Companies
(주)메디탑
Product
메디탑소독용에탄올
Original text
품질부적합(함량)
Key facts · Basis: Intake raw
Grounds: quality nonconformity in assay
Product: a disinfectant ethanol preparation
Recall order date: 20260902, mandatory: Y
Insight · Editorial insight
For ethanol preparations, assay directly reflects whether the actual active level matches the labelled content. Quality assurance functions should confirm that the basis for the assay specification accounts for evaporative loss during packaging and storage.
Check points
Basis for setting the assay specification for ethanol preparations
Assessment of the effect of packaging and storage conditions on assay
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
A recall and sales suspension was ordered for a disinfectant ethanol product on the ground of quality nonconformity in assay.
Published
2026-09-02
Document no.
recall-d302fef7af44
Companies
주식회사 에이탑메드
Product
에이탑소독용에탄올
Original text
품질부적합(함량)
Key facts · Basis: Intake raw
Grounds: quality nonconformity in assay
Product: a disinfectant ethanol preparation
Recall order date: 20260902, mandatory: Y
Insight · Editorial insight
Where an assay nonconformity is confirmed in a particular manufacturing lot, the reproducibility of the mixing and dilution process is generally the first area examined. Quality assurance functions should check that assay results are trended by lot and that evidence of process reproducibility exists.
Check points
Trending of assay results by manufacturing lot
Evidence confirming reproducibility of the mixing and dilution process
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
A recall and sales suspension was ordered for a disinfectant ethanol product on the ground of quality nonconformity in assay.
Published
2026-09-02
Document no.
recall-f004a2ec6d2a
Companies
주식회사다나제약
Product
다나소독용에탄올
Original text
품질부적합(함량)
Key facts · Basis: Intake raw
Grounds: quality nonconformity in assay
Product: a disinfectant ethanol preparation
Recall order date: 20260902, mandatory: Y
Insight · Editorial insight
An assay nonconformity in the finished product can only be narrowed down by tracing back to the measured assay of the incoming material and the basis for the batch calculation. Quality assurance functions should confirm that incoming material test results and any assay correction applied in the batch calculation are documented.
Check points
Incoming material test results and the basis for assay correction
Verification and approval records for batch calculations
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Grounds: quality nonconformity in assay, identified in one hand sanitiser gel containing ethanol (95)
Scope: 25 products containing ethanol (95) recalled together
Recall order date: 20260831, mandatory: Y
Insight · Editorial insight
An assay nonconformity confirmed in one product was handled as a recall covering 25 products. Quality assurance functions should confirm how a test result for one product feeds into the disposition of the remaining products in a range marketed under multiple names.
Check points
Criteria for applying test results across products within the same range
Basis for determining recall scope in a multi-product recall
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall / sales suspension · MFDS]주식회사한국미라클피플사 — Hand sanitiser gel assay nonconformity
Evidence AMFDSSignal High · T3💊 Small moleculeRecall
A recall and sales suspension was ordered for a hand sanitiser gel containing ethanol (95) on the ground of quality nonconformity in assay.
Published
2026-08-31
Document no.
recall-9572a31469b1
Companies
주식회사한국미라클피플사
Product
1.케이엠피씨미라클오리진핸드세니타이저겔(에탄올(95))
Original text
품질부적합(함량)
Key facts · Basis: Intake raw
Grounds: quality nonconformity in assay
Product: a hand sanitiser gel containing ethanol (95)
Recall order date: 20260831, mandatory: Y
Insight · Editorial insight
For gels with ethanol as the active ingredient, assay results can shift with sampling and storage conditions, so control of test conditions governs the reliability of the disposition. Quality assurance functions should confirm that sampling timing and closure conditions for assay testing of alcohol preparations are fixed by procedure.
Check points
Sampling and storage conditions for assay testing of alcohol preparations
Basis for setting the specification relative to the labelled content
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Evidence AMFDSSignal High · T3💊 Small moleculeRecall
A voluntary recall of distributed stock was carried out for a repaglinide tablet product after the impurity N-nitroso-meglumine was detected above the limit. Three products differing in strength are covered by the same recall.
Published
2026-08-19
Document no.
recall-582b877528db
Companies
(주)다림바이오텍
Product
레파넘정2밀리그람(레파글리니드) 외 2품목
All 3 products
레파넘정2밀리그람(레파글리니드)
레파넘정0.5밀리그램(레파글리니드)
레파넘정1밀리그램(레파글리니드)
Original text
불순물(N-nitroso-meglumine) 초과 검출에 따른 시중 유통품에 대한 영업자 회수
Key facts · Basis: Intake raw
Grounds: voluntary recall of distributed stock following detection of the impurity N-nitroso-meglumine above the limit
Scope: three repaglinide tablet products recalled together on the same grounds
Classification: mandatory N, voluntary recall; recall order date 20260819
Published: 2026-08-19
Insight · Editorial insight
Nitrosamine impurities continue to appear as recall grounds in particular combinations of active ingredient and excipient. Quality and regulatory affairs functions should confirm that amine-containing excipient combinations are reflected in the list of products subject to nitrosamine risk assessment.
Check points
Currency of the list of products subject to nitrosamine impurity risk assessment
Impurity testing criteria for products using amine-containing excipients
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall · FDA]Buy-Herbal — Recall for undeclared drug ingredients
Evidence AFDASignal High · T3💊 Small moleculeRecall
FDA published a recall of Kian Pee Wan Capsules from Buy-Herbal because the product contains undeclared drug ingredients.
Published
2026-08-19
Document no.
D-0769-2026
Companies
Buy-Herbal
Product
Kian Pee Wan Capsules, 30-count bottles
Class
Class I
Original text and translation
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Key facts · Basis: Intake raw
Grounds: marketed without an approved NDA or ANDA, containing the undeclared drug ingredients dexamethasone and cyproheptadine
Recall class: Class I
Product: Kian Pee Wan Capsules, 30-count bottles
Insight · Editorial insight
A product presented as herbal containing undeclared drug ingredients was classified at the highest hazard level. Quality assurance functions should check that testing is in place to screen for undeclared ingredients entering through imported materials or contract manufacturing routes.
Check points
Test methods established to detect undeclared drug ingredients
Procedure for verifying that supply chain materials match their declared composition
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall · FDA]Victory Medical Center Pharmacy — Injection out of endotoxin specification
Evidence AFDASignal High · T3💊 Small moleculeRecall
FDA published a recall of Glutathione injection from Victory Medical Center Pharmacy following out-of-specification results for bacterial endotoxin.
Published
2026-08-19
Document no.
D-0772-2026
Companies
Victory Medical Center Pharmacy
Product
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, A…
Class
Class I
Original text and translation
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Key facts · Basis: Intake raw
Grounds: microbial contamination of sterile products, with out-of-specification results obtained for bacterial endotoxin
Recall class: Class I
Product: Glutathione (MDV), 200 mg/mL, 30 mL vial
Insight · Editorial insight
An endotoxin excursion in a compounded injection points to failed control of endotoxin load in water and materials, not only to sterility. Sterile product sites should confirm that endotoxin limits and testing frequency for water for injection and raw materials are consistent with the product specification.
Check points
Basis for endotoxin control limits for water for injection and raw materials
Endotoxin testing frequency and the procedure for handling out-of-specification results
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Because the particulates span plastic, metal and glass, the source cannot be attributed to a single step and has to be traced across the whole filling line. Injectable manufacturers should confirm they can map particulate sources by material and verify the detection capability of their line inspection methods.
Check points
Mapping and traceability of particulate sources by material type
Verification of the detection limit of particulate inspection methods on the filling line
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall (Health Canada) · Health Canada]JAMP Pharma Corporation — Temozolomide out of assay specification
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada published a recall of JAMP Temozolomide capsules from JAMP Pharma Corporation for a product quality issue, with an out-of-specification assay result given as the reason.
Published
2026-08-31
Document no.
hc-82571
Companies
JAMP Pharma Corporation
Product
JAMP Temozolomide
Class
Type II
Original text and translation
Product quality
Key facts · Basis: Intake raw
Grounds: product quality, out-of-specification assay result
Recall class: Type II
Product: JAMP Temozolomide 140 mg capsules
Action: patients advised to check whether stock on hand is affected and to consult a healthcare professional before stopping use
Insight · Editorial insight
An out-of-specification assay in an oncology product directly affects dose accuracy and carries a high clinical impact. Quality assurance functions should confirm that content uniformity testing for cytotoxic capsules is adequately designed and that assay trends are monitored through stability testing.
Check points
Design of content uniformity testing for cytotoxic capsule products
Criteria for monitoring assay trends during stability testing
Recall detail · From the source · Health Canada
Active ingredient · 140 mgDosage 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, 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.
Dissolution failures can arise from process variables or from change during storage, so establishing when the failure appeared is the starting point for root cause work. Quality assurance functions should review the basis for dissolution test conditions and time points for solid dosage forms and how dissolution trends are monitored through stability testing.
Check points
Basis for dissolution test conditions and time points for solid dosage forms
Monitoring of dissolution result trends during stability testing
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall · FDA]Apollo Care, LLC SEMAGLUTIDE 12.5MG (2. — Semaglutide recalled for particulate matter
Evidence AFDASignal Med · T2💊 Small moleculeRecall
FDA published a recall of 11 products from Apollo Care, LLC, including semaglutide injection, because of particulate matter. Several products were recalled together on the same grounds.
Published
2026-08-19
Document no.
D-0747-2026
Companies
Apollo Care, LLC
Product
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05 외 10품목
Class
Class II
All 11 products
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.
Original text and translation
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Key facts · Basis: Intake raw
Grounds: presence of particulate matter identified as nylon or polyamide and silk or proteinaceous-type material
Recall class: Class II
Scope: 11 products recalled together on the same grounds
Insight · Editorial insight
Particulates identified as nylon and proteinaceous material are generally associated with process consumables such as garments and filter media. Aseptic compounding and filling operations should confirm they have assessed the shedding characteristics of the materials used and identified control points for particulates after final filtration.
Check points
Assessment of fibre shedding characteristics for aseptic processing consumables
Particulate inspection and control points after final filtration
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall · FDA]Shoolin Pharma Chem LLP SILDENAFIL CITRATE USP, 0. — API recalled over CGMP deviations
Evidence AFDASignal Med · T2💊 Small moleculeRecall
FDA published a recall of five products from Shoolin Pharma Chem LLP, including active pharmaceutical ingredients for compounding, because of CGMP deviations noted during an FDA inspection.
Published
2026-08-19
Document no.
D-0759-2026
Companies
Shoolin Pharma Chem LLP
Product
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05 외 4품목
Class
Class II
All 5 products
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
Original text and translation
CGMP Deviations:Noted during FDA inspection
Key facts · Basis: Intake raw
Grounds: CGMP deviations noted during FDA inspection
Recall class: Class II
Scope: five products recalled together, including active pharmaceutical ingredients labelled for prescription compounding only
Insight · Editorial insight
The inspection outcome alone led to a recall of distributed material, without any batch-specific test failure. Quality assurance functions should monitor the inspection history and regulatory actions affecting overseas API suppliers and maintain a plan for alternative supply should a recall occur.
Check points
Monitoring of inspection history and regulatory actions at overseas API suppliers
Alternative supplier and inventory impact assessment in the event of an API recall
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Evidence AFDASignal Med · T2💊 Small moleculeRecall
FDA published a recall of CLEAR EYES Maximum Itchy Eye Relief eye drops from Prestige Brands Holdings for lack of assurance of sterility.
Published
2026-08-19
Document no.
D-0766-2026
Companies
Prestige Brands Holdings
Product
CLEAR EYES Maximum Itchy Eye Relief, 0.
Class
Class II
Original text and translation
①Lack of assurance of sterility.
②The recall is due to potential contamination
Key facts · Basis: Intake raw
Grounds: lack of assurance of sterility, with the recall due to potential contamination
Recall class: Class II
Product: CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) dropper bottle
Insight · Editorial insight
Sterility of an ophthalmic product is judged on the evidence that the whole process assures it, not on an individual test result. Ophthalmic manufacturers should confirm that aseptic process validation and container closure integrity data actually support the sterility claim.
Check points
Evidence supporting aseptic process validation for ophthalmic products
Design and frequency of container closure integrity testing
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
[Recall · FDA]Heritage Pharmaceuticals Inc — Particles and flakes after reconstitution
Evidence AFDASignal Med · T2💊 Small moleculeRecall
FDA published a recall of clindamycin palmitate hydrochloride for oral solution from Heritage Pharmaceuticals Inc after particles and white flakes were found in reconstituted bottles.
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Key facts · Basis: Intake raw
Grounds: presence of foreign substance, with particles and white flakes found in the reconstituted bottles
Recall class: Class II
Product: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, 100 mL
Insight · Editorial insight
The foreign matter appeared only after reconstitution, so inspection of the dry powder alone would not have detected it. Quality assurance functions should confirm that appearance and particulate checks after reconstitution are included in the specification and reflected in the stability study design for dry syrup products.
Check points
Whether appearance and particulate testing after reconstitution is included in the specification for dry syrup products
Whether reconstituted conditions are reflected in the stability study design
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Evidence AFDASignal Med · T2💊 Small moleculeRecall
FDA published a recall of three products from Ascend Laboratories, LLC, including dabigatran etexilate capsules, because of out-of-specification impurity results found at the 12-month stability time point.
Published
2026-08-05
Document no.
D-0737-2026
Companies
Ascend Laboratories, LLC
Product
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68. 외 2품목
Class
Class III
All 3 products
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Original text and translation
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Key facts · Basis: Intake raw
Grounds: failed impurity and degradation specification, with OOS results in related substance testing for Impurity II, Impurity III and total impurities at 12-month stability
Recall class: Class III
Scope: three products recalled together, including Dabigatran Etexilate Capsules, 150 mg
Insight · Editorial insight
Impurities moved outside specification at an intermediate stability time point, which puts the basis for the assigned shelf life itself under review. Quality assurance functions should confirm they have a system for trending stability results and a procedure for assessing the impact of a stability OOS on shelf life and distributed stock.
Check points
System for trend analysis of impurity results from stability testing
Procedure for assessing shelf life and distributed stock impact when a stability OOS occurs
The detailed findings for this card are a record published in Korean by a Korean regulator, so they are not included in the English edition. They are available in the Korean edition.
Card titles, summaries, Korean translations, implications, check items, and detailed analysis are content generated automatically by generative AI from published primary official material.
2. Information provided as in the source
Figures, codes, dates, agency and company names in the fact table, quotations from the original text, source and official-document links, and findings tables (FDA Form 483 observations, MFDS routine inspection findings, and so on) are extracted mechanically from the source and are not reworded or rewritten.
3. Verification, limitations, and user notes
To improve accuracy, GRM provides evidence grades (A, B, C) and signal tiers (1–3). Evidence A means the information can be checked directly against a primary official document.
Summaries, translations, implications, check items, and detailed analysis generated by generative AI may contain mistranslations, omissions, misread context, or information that is not up to date.
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