Global Regulatory Monitor Regulatory News, Week 2 · 2026/10
Period 2026-10-05 ~ 2026-10-12Published 2026-10-12Collected 94 · 25 cardsEvidence A 21 · B 4 · C 0
9 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
The Dutch authority found a hospital pharmacy GMP non-compliant over critical deficiencies including release of an ATMP after a failed sterility test, and suspended a clinical trial.
An FDA 483 to RC Outsourcing cites inadequate investigation of four repackaged Avastin batches that failed sterility and release of same-day, same-hood batches.
MFDS imposed a 3-month manufacturing suspension on one product of a manufacturer for a quality nonconformity.
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.
[EU GMP non-compliance · EMA]Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Zieke… — GMP non-compliance in IMP manufacture
Evidence AEMASignal High · T3🧬 BiologicsGMP non-compliance
The Dutch authority found the investigational medicinal product activities of a hospital pharmacy, Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis, GMP non-compliant. The decision rests on 1 critical deficiency (inadequate OOS handling) and 7 major deficiencies, and one EU clinical trial (M22BOL) is suspended.
Published
2026-10-08
Document no.
188001
Site / company
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting (Netherlands)
Issuing authority (NCA)
Netherlands
Product scope
Human Investigational Medicinal Products
Original text and translation
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026.
Key facts · Basis: official source record kept by the collector
Basis: 1 critical, 7 major and 14 other deficiencies
Critical: batches released despite failing moisture or assay limits; an ATMP released after a failed in-process sterility test
Action: suspension of clinical trial EU CT 2023-505039-11-00 (M22BOL); withdrawal of four GMP certificates
Scope: aseptic lyophilisates, small volume liquids, cell and gene therapy products, tablets and hard capsules
Insight · Editorial insight
The authority applied the same OOS and quality system standard to a hospital pharmacy's investigational products as to commercial manufacture, and tied it to a trial suspension. Sponsors that outsource IMP relabeling or repackaging should verify the contractor's OOS procedure and batch certification basis directly.
Check points
OOS investigation and batch certification procedure at IMP contractors
Validity of GMP certificates held by IMP relabeling and repackaging contractors
Non-compliance detail · From the source · EudraGMDP
1.1.1Aseptically prepared (processing operations for the following dosage forms)
1.1.1.2Lyophilisates
1.1.1.4Small volume liquids
1.1.1.6Other: cell therapy products and gene therapy products(en)
1.2Non-sterile products
1.2.1Non-sterile products (processing operations for the following dosage forms)
1.2.1.1Capsules, hard shell
1.2.1.13Tablets
1.3Biological medicinal products (list of product types)
1.3.1Biological medicinal products (list of product types)
1.3.1.3Cell therapy products
1.3.1.4Gene therapy products
1.3.1.5Biotechnology products
1.5Packaging
1.5.1Primary Packaging
1.5.1.1Capsules, hard shell
1.5.1.13Tablets
1.5.2Secondary packaging
Nature of non-compliance
Original · EudraGMDP
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026. This manufacturer, a hospital pharmacy, is producing multiple type of products: medicinal products for human use with a marketing authorization, advanced therapy medicinal products (ATMPs, investigational) and human investigational medicines. It concerns sterile production of registered products and ATMPs and non-sterile production of registered products. In addition, the activities of investigational medicinal products are manufacturing of tablets/capsules, and relabeling and repackaging. All of the clinical studies are performed in the Netherlands, except one study is performed in Europe (M22BOL EU CT 2023-505039-11-00). The outcome of the inspection was GMP non-compliant, which is based on one (1) critical deficiency, seven (7) major deficiencies and fourteen (14) other deficiencies. In summary the main inspection findings were as follows: Critical deficiency:
1) The execution of the Out-of-Specification (OOS) process is inadequate. In practice, multiple batches of registered finished products were released even though they did not comply with the specified limits for moisture content or assay. An Advanced Therapy Medicinal Product (ATMP) was released despite a failed sterility test which was performed as an in-process control. In addition, the procedure for OOS is not unambiguous and can lead to batch certification and release without thorough investigation of sufficient justification. Major deficiencies:
1) The control of aseptic practices for both the registered product and the ATMP manufacturing process is insufficient e.g. Annex1 gap assessment and the contamination control strategy are incomplete. Regarding ATMP production multiple aspects are not under control.
2) Aseptic process simulation is inadequate for both the registered product and the ATMP process, including the additional media fill.
3) The design, investigation and trending of microbiological test results are insufficient for example multiple microbial exceedances on the hands of the operators in class A handling the ATMP product.
4) Operator behaviour in the cleanroom and gowning procedures for Grade B areas are inadequate.
5) The Pharmaceutical Quality System (PQS) is insufficient. This is shown by deficiencies identified in the management of deviations, CAPAs, changes, complaints, self-inspections, and the Product Quality Reviews (PQRs) that were assessed.
6) The approach to Computerized System Validation (CSV) and data integrity is inadequate.
7) Good Documentation Practices (GDocP) are not sufficiently adhered to, as demonstrated for example by the backlog of revisions for multiple documents. In conclusion: the impact of the GMP non-compliance on registered products, ATMPs and most of the investigational medicinal products is exclusively national, except for one clinical study (EU CT 2023-505039-11-00)(see paragraph: suspension of clinical trials).
Action taken/proposed
Original · EudraGMDP
Suspension of clinical trials For the EU only one product is impacted: M22BOL study (EU CT 2023-505039-11-00). The activities relabeling and repackaging of DS-8201a (trastuzumab deruxtecan). All the other products are solely present on the Dutch market. Impact: The impact of the inspection findings for EU CT 2023-505039-11-00, where a registered product will be relabeled and repacked by NKI/AVL, will be limited. This is an existing and released medicinal product. The critical shortcoming plus four major shortcomings regarding sterile manufacturing and aseptic production do not affect this investigational medicinal product. However, major shortcomings regarding the Quality Management system, Computer System Validation and Good Documentation practice could affect this investigational medicinal product. Recommendations: Up to this moment, four patients out of the expected total amount of 72 patients have been treated since the start of the clinical trial May, 2, 2024. Those four patients were treated in the Netherlands. It is up to the concerned Member States to make a decision regarding their market taking into account the legal frameworks. Others Withdrawal of GMP certificates NL/H 24/2051740A, NL/H 24/2051740B, NL/H 24/2051740C and NL/H 24/2051740D. A re-inspection will be performed on the basis of the company's plan of action to address the deficiencies (currently not scheduled yet). After a positive result following the re-inspection an new GMP-certificate will be issued and this non-compliance statement will be withdrawn.
Further comments
Original · EudraGMDP
No need for a teleconference since the impact is restricted.
[EU GMP non-compliance · EMA]Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Zieke… — Aseptic lyophilisate GMP non-compliance
Evidence AEMASignal High · T3🧬 BiologicsGMP non-compliance
The Dutch authority found the authorised-product operations of Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis (aseptic lyophilisates, other solid dosage forms, packaging) GMP non-compliant and withdrew the related GMP certificates. Inadequate OOS handling, including release of batches failing moisture or assay limits, was the critical deficiency.
Published
2026-10-07
Document no.
187962
Site / company
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting (Netherlands)
Issuing authority (NCA)
Netherlands
Product scope
Human Medicinal Products
Original text and translation
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026.
Key facts · Basis: official source record kept by the collector
Operations covered: aseptic lyophilisates, other solid dosage forms, primary and secondary packaging
Action: withdrawal of GMP certificates NL/H 24/2051740A and B (including C and D at Plesmanlaan 121)
Major deficiencies: insufficient control of aseptic practices, inadequate aseptic process simulation (media fill), inadequate cleanroom behaviour and gowning
Re-inspection: planned on the basis of the company's action plan (not yet scheduled)
Insight · Editorial insight
An incomplete Annex 1 gap assessment and contamination control strategy translated directly into non-compliance for authorised sterile products. For aseptic lyophilisation lines, CCS completeness and media fill design are first-line inspection targets.
Check points
Completeness of Annex 1 gap assessment and contamination control strategy
Representativeness of aseptic process simulation, including interventions and operators
Non-compliance detail · From the source · EudraGMDP
Issuing NCA · NetherlandsHuman Medicinal Products
Non-compliant operations
Original · EudraGMDP
1NON-COMPLIANT MANUFACTURING OPERATIONS
1.1Sterile products
1.1.1Aseptically prepared (processing operations for the following dosage forms)
1.1.1.2Lyophilisates
1.2Non-sterile products
1.2.1Non-sterile products (processing operations for the following dosage forms)
1.2.1.8Other solid dosage forms
1.5Packaging
1.5.1Primary Packaging
1.5.1.8Other solid dosage forms
1.5.2Secondary packaging
Nature of non-compliance
Original · EudraGMDP
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026. This manufacturer, a hospital pharmacy, is producing multiple type of products: medicinal products for human use with a marketing authorization, advanced therapy medicinal products (ATMPs, investigational) and human investigational medicines. It concerns sterile production of registered products and ATMPs and non-sterile production of registered products. In addition, the activities of investigational medicinal products are manufacturing of tablets/capsules, and relabeling and repackaging. All of the clinical studies are performed in the Netherlands, except one study is performed in Europe (M22BOL EU CT 2023-505039-11-00). The outcome of the inspection was GMP non-compliant, which is based on one (1) critical deficiency, seven (7) major deficiencies and fourteen (14) other deficiencies. In summary the main inspection findings were as follows: Critical deficiency:
1) The execution of the Out-of-Specification (OOS) process is inadequate. In practice, multiple batches of registered finished products were released even though they did not comply with the specified limits for moisture content or assay. An Advanced Therapy Medicinal Product (ATMP) was released despite a failed sterility test which was performed as an in-process control. In addition, the procedure for OOS is not unambiguous and can lead to batch certification and release without thorough investigation of sufficient justification. Major deficiencies:
1) The control of aseptic practices for both the registered product and the ATMP manufacturing process is insufficient e.g. Annex1 gap assessment and the contamination control strategy are incomplete. Regarding ATMP production multiple aspects are not under control.
2) Aseptic process simulation is inadequate for both the registered product and the ATMP process, including the additional media fill.
3) The design, investigation and trending of microbiological test results are insufficient for example multiple microbial exceedances on the hands of the operators in class A handling the ATMP product.
4) Operator behaviour in the cleanroom and gowning procedures for Grade B areas are inadequate.
5) The Pharmaceutical Quality System (PQS) is insufficient. This is shown by deficiencies identified in the management of deviations, CAPAs, changes, complaints, self-inspections, and the Product Quality Reviews (PQRs) that were assessed.
6) The approach to Computerized System Validation (CSV) and data integrity is inadequate.
7) Good Documentation Practices (GDocP) are not sufficiently adhered to, as demonstrated for example by the backlog of revisions for multiple documents. In conclusion: the impact of the GMP non-compliance on registered products, ATMPs and most of the investigational medicinal products is exclusively national, except for one clinical study (EU CT 2023-505039-11-00)(see paragraph: suspension of clinical trials).
Action taken/proposed
Original · EudraGMDP
Withdrawal, of current valid GMP certificate No. NL/H 24/2051740A, NL/H 24/2051740B Including the GMP certificates of the Plesmanlaan 121, Amsterdam e.g. NL/H 24/2051740C and NL/H 24/2051740D. A re-inspection will be performed on the basis of the company's plan of action to address the deficiencies (currently not scheduled yet). After a positive result following the re-inspection a new GMP certificate will be issued and this non-compliance statement will be withdrawn. Suspension of clinical trials For the EU only one product is impacted: M22BOL study (EU CT 2023-505039-11-00). The activities are relabeling and repackaging of DS-8201a (trastuzumab deruxtecan). All the other products are solely present on the Dutch market. Impact: The impact of the inspection findings for EU CT 2023-505039-11-00, where a registered product will be relabeled and repacked by NKI/AVL, will be limited. This is an existing and released medicinal product. The critical shortcoming plus the four major shortcomings regarding sterile manufacturing and aseptic production do not affect this investigational medicinal product. However, major shortcomings regarding the Quality Management System, Computer System Validation and Good Documentation practice could affect this investigational medicinal product. Recommendations: Up to this moment, four patients out of the expected total amount of 72 patients have been treated since the start of the clinical trial May, 2, 2024. Those four patients were treated in the Netherlands. It is up to the concerned Member States to make a decision regarding their market taking into account the legal frameworks.
Further comments
Original · EudraGMDP
No need for a teleconference since the impact is restricted.
[EU GMP non-compliance · EMA]Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Zieke… — Batch certification and QC non-compliance
Evidence AEMASignal High · T3🧬 BiologicsGMP non-compliance
The Dutch authority found the batch certification and quality control testing activities (sterility, microbiological, chemical/physical and biological testing) of Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis GMP non-compliant. The critical deficiency was an ambiguous OOS procedure that can lead to batch certification and release without thorough investigation.
Published
2026-10-07
Document no.
187963
Site / company
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting (Netherlands)
Issuing authority (NCA)
Netherlands
Product scope
Human Medicinal Products
Original text and translation
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026.
Key facts · Basis: official source record kept by the collector
Operations covered: batch certification of sterile and non-sterile products; sterility, microbiological, chemical/physical and biological testing
Critical: ambiguous OOS procedure allowing certification and release without thorough investigation or justification
Major: insufficient design, investigation and trending of microbiological results (multiple exceedances on operators' hands in class A)
Action: withdrawal of GMP certificates NL/H 24/2051740C and D (including A and B at Louwesweg 6)
Insight · Editorial insight
By naming QC testing and batch certification themselves as non-compliant operations, the authority targeted the control between a laboratory OOS result and the release decision. Whether environmental monitoring exceedances are trended and investigated is a key QC checkpoint.
Check points
Controls that block batch certification before an OOS is resolved
Linking operator hand and glove EM exceedances to trending and investigation
Non-compliance detail · From the source · EudraGMDP
Issuing NCA · NetherlandsHuman Medicinal Products
Non-compliant operations
Original · EudraGMDP
1NON-COMPLIANT MANUFACTURING OPERATIONS
1.1Sterile products
1.1.3Batch certification
1.2Non-sterile products
1.2.2Batch certification
1.6Quality control testing
1.6.1Microbiological: sterility
1.6.2Microbiological: non-sterility
1.6.3Chemical/Physical
1.6.4Biological
Nature of non-compliance
Original · EudraGMDP
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026. This manufacturer, a hospital pharmacy, is producing multiple type of products: medicinal products for human use with a marketing authorization, advanced therapy medicinal products (ATMPs, investigational) and human investigational medicines. It concerns sterile production of registered products and ATMPs and non-sterile production of registered products. In addition, the activities of investigational medicinal products are manufacturing of tablets/capsules, and relabeling and repackaging. All of the clinical studies are performed in the Netherlands, except one study is performed in Europe (M22BOL EU CT 2023-505039-11-00). The outcome of the inspection was GMP non-compliant, which is based on one (1) critical deficiency, seven (7) major deficiencies and fourteen (14) other deficiencies. In summary the main inspection findings were as follows: Critical deficiency:
1) The execution of the Out-of-Specification (OOS) process is inadequate. In practice, multiple batches of registered finished products were released even though they did not comply with the specified limits for moisture content or assay. An Advanced Therapy Medicinal Product (ATMP) was released despite a failed sterility test which was performed as an in-process control. In addition, the procedure for OOS is not unambiguous and can lead to batch certification and release without thorough investigation of sufficient justification. Major deficiencies:
1) The control of aseptic practices for both the registered product and the ATMP manufacturing process is insufficient e.g. Annex1 gap assessment and the contamination control strategy are incomplete. Regarding ATMP production multiple aspects are not under control.
2) Aseptic process simulation is inadequate for both the registered product and the ATMP process, including the additional media fill.
3) The design, investigation and trending of microbiological test results are insufficient for example multiple microbial exceedances on the hands of the operators in class A handling the ATMP product.
4) Operator behaviour in the cleanroom and gowning procedures for Grade B areas are inadequate.
5) The Pharmaceutical Quality System (PQS) is insufficient. This is shown by deficiencies identified in the management of deviations, CAPAs, changes, complaints, self-inspections, and the Product Quality Reviews (PQRs) that were assessed.
6) The approach to Computerized System Validation (CSV) and data integrity is inadequate.
7) Good Documentation Practices (GDocP) are not sufficiently adhered to, as demonstrated for example by the backlog of revisions for multiple documents. In conclusion: the impact of the GMP non-compliance on registered products, ATMPs and most of the investigational medicinal products is exclusively national, except for one clinical study (EU CT 2023-505039-11-00)(see paragraph: suspension of clinical trials).
Action taken/proposed
Original · EudraGMDP
Withdrawal, of current valid GMP certificate No. NL/H 24/2051740C, NL/H 24/2051740D Including the GMP certificates of Louwesweg 6, Amsterdam e.g. NL/H 24/2051740A and NL/H 24/2051740B. A re-inspection will be performed on the basis of the company's plan of action to address the deficiencies (currently not scheduled yet). After a positive result following the re-inspection a new GMP certificate will be issued and this non-compliance statement will be withdrawn. Suspension of clinical trials For the EU only one product is impacted: M22BOL study (EU CT 2023-505039-11-00). The activities are relabeling and repackaging of DS-8201a (trastuzumab deruxtecan). All the other products are solely present on the Dutch market. Impact: The impact of the inspection findings for EU CT 2023-505039-11-00, where a registered product will be relabeled and repacked by NKI/AVL, will be limited. This is an existing and released medicinal product. The critical shortcoming plus the four major shortcomings regarding sterile manufacturing and aseptic production do not affect this investigational medicinal product. However, major shortcomings regarding the Quality Management System, Computer System Validation and Good Documentation practice could affect this investigational medicinal product. Recommendations: Up to this moment, four patients out of the expected total amount of 72 patients have been treated since the start of the clinical trial May, 2, 2024. Those four patients were treated in the Netherlands. It is up to the concerned Member States to make a decision regarding their market taking into account the legal frameworks.
Further comments
Original · EudraGMDP
No need for a teleconference since the impact is restricted.
[EU GMP non-compliance · EMA]Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Zieke… — ATMP aseptic manufacture non-compliance
Evidence AEMASignal High · T3🧬 BiologicsGMP non-compliance
The Dutch authority found the investigational ATMP operations of Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis (aseptic manufacture of cell and gene therapy products, batch certification, QC testing) GMP non-compliant. The critical deficiency includes the release of an ATMP despite a failed in-process sterility test.
Published
2026-10-07
Document no.
187964
Site / company
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting (Netherlands)
Issuing authority (NCA)
Netherlands
Product scope
Human Investigational Medicinal Products
Original text and translation
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026.
Key facts · Basis: official source record kept by the collector
Operations covered: aseptic manufacture of cell and gene therapy products, batch certification of biologicals, secondary packaging, QC testing
Critical: inadequate OOS handling, including release of an ATMP after a failed in-process sterility test
Major: multiple aspects of ATMP production not under control; multiple microbial exceedances on operators' hands in class A
Action: withdrawal of GMP certificates NL/H 24/2051740C and D; suspension of the M22BOL trial
Insight · Editorial insight
Even when the sterility test is an in-process control, releasing an ATMP over a failed result is judged a critical deficiency. Cell and gene therapy sites should state explicitly in their release procedure how an in-process sterility failure is dispositioned.
Check points
ATMP release criteria after an in-process sterility failure
Handling of hand monitoring results for ATMP aseptic operators
Non-compliance detail · From the source · EudraGMDP
1.1.1Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6Other: cell therapy products and gene therapy products(en)
1.1.3Batch certification
1.2Non-sterile products
1.2.2Batch certification
1.3Biological medicinal products (list of product types)
1.3.1Biological medicinal products (list of product types)
1.3.1.3Cell therapy products Special Requirements:
3Live Cells
1.3.1.4Gene therapy products Special Requirements:
3Live Cells
1.3.1.5Biotechnology products Special Requirements:
3Live Cells
1.3.2Batch Certification (list of product types)
1.3.2.3Cell therapy products
1.3.2.4Gene therapy products
1.3.2.5Biotechnology products
1.5Packaging
1.5.2Secondary packaging
1.6Quality control testing
1.6.1Microbiological: sterility
1.6.2Microbiological: non-sterility
1.6.3Chemical/Physical
1.6.4Biological
Nature of non-compliance
Original · EudraGMDP
The GMP inspection has been performed on February 10–12, 2026 and April 22-23, 2026. This manufacturer, a hospital pharmacy, is producing multiple type of products: medicinal products for human use with a marketing authorization, advanced therapy medicinal products (ATMPs, investigational) and human investigational medicines. It concerns sterile production of registered products and ATMPs and non-sterile production of registered products. In addition, the activities of investigational medicinal products are manufacturing of tablets/capsules, and relabeling and repackaging. All of the clinical studies are performed in the Netherlands, except one study is performed in Europe (M22BOL EU CT 2023-505039-11-00). The outcome of the inspection was GMP non-compliant, which is based on one (1) critical deficiency, seven (7) major deficiencies and fourteen (14) other deficiencies. In summary the main inspection findings were as follows: Critical deficiency:
1) The execution of the Out-of-Specification (OOS) process is inadequate. In practice, multiple batches of registered finished products were released even though they did not comply with the specified limits for moisture content or assay. An Advanced Therapy Medicinal Product (ATMP) was released despite a failed sterility test which was performed as an in-process control. In addition, the procedure for OOS is not unambiguous and can lead to batch certification and release without thorough investigation of sufficient justification. Major deficiencies:
1) The control of aseptic practices for both the registered product and the ATMP manufacturing process is insufficient e.g. Annex1 gap assessment and the contamination control strategy are incomplete. Regarding ATMP production multiple aspects are not under control.
2) Aseptic process simulation is inadequate for both the registered product and the ATMP process, including the additional media fill.
3) The design, investigation and trending of microbiological test results are insufficient for example multiple microbial exceedances on the hands of the operators in class A handling the ATMP product.
4) Operator behaviour in the cleanroom and gowning procedures for Grade B areas are inadequate.
5) The Pharmaceutical Quality System (PQS) is insufficient. This is shown by deficiencies identified in the management of deviations, CAPAs, changes, complaints, self-inspections, and the Product Quality Reviews (PQRs) that were assessed.
6) The approach to Computerized System Validation (CSV) and data integrity is inadequate.
7) Good Documentation Practices (GDocP) are not sufficiently adhered to, as demonstrated for example by the backlog of revisions for multiple documents. In conclusion: the impact of the GMP non-compliance on registered products, ATMPs and most of the investigational medicinal products is exclusively national, except for one clinical study (EU CT 2023-505039-11-00)(see paragraph: suspension of clinical trials).
Action taken/proposed
Original · EudraGMDP
Withdrawal, of current valid GMP certificate No. NL/H 24/2051740C, NL/H 24/2051740D Including the GMP certificates of Louwesweg 6, Amsterdam e.g. NL/H 24/2051740A and NL/H 24/2051740B. A re-inspection will be performed on the basis of the company's plan of action to address the deficiencies (currently not scheduled yet). After a positive result following the re-inspection a new GMP certificate will be issued and this non-compliance statement will be withdrawn. Suspension of clinical trials For the EU only one product is impacted: M22BOL study (EU CT 2023-505039-11-00). The activities are relabeling and repackaging of DS-8201a (trastuzumab deruxtecan). All the other products are solely present on the Dutch market. Impact: The impact of the inspection findings for EU CT 2023-505039-11-00, where a registered product will be relabeled and repacked by NKI/AVL, will be limited. This is an existing and released medicinal product. The critical shortcoming plus the four major shortcomings regarding sterile manufacturing and aseptic production do not affect this investigational medicinal product. However, major shortcomings regarding the Quality Management System, Computer System Validation and Good Documentation practice could affect this investigational medicinal product. Recommendations: Up to this moment, four patients out of the expected total amount of 72 patients have been treated since the start of the clinical trial May, 2, 2024. Those four patients were treated in the Netherlands. It is up to the concerned Member States to make a decision regarding their market taking into account the legal frameworks.
Further comments
Original · EudraGMDP
No need for a teleconference since the impact is restricted.
FDA issued a Form 483 with eight observations to the outsourcing facility RC Outsourcing LLC. The observations include undocumented airflow visualization (smoke) studies, inadequate sterility failure investigations for repackaged Avastin, and problems with cleanroom flow and cleaning intervals.
Published
2026-10-06
Document no.
fda483-195189
Site / company
RC Outsourcing LLC · FEI 3011967886
Site · type
Outsourcing Facility · 483
Inspection date
09/03/2026
Key facts · Basis: official index plus supporting sources
Observation 1: no protocols or reports for airflow visualization studies of the ISO 5 hoods
Observation 2: four batches of repackaged Avastin 1.25 mg/0.05 mL rejected for sterility failures since October 2025, while same-day, same-hood batches were released without justification
Observation 4: a 49-day gap in cleanroom cleaning and no scientifically based cleaning intervals
Observation 6: no rationale for the subvisible particle specification of Avastin 1.75 mg/0.07 mL (repeat observation; lots linked to endophthalmitis events were released)
Insight · Editorial insight
The key finding is the decision to reject only the failed batches while releasing others made the same day in the same hood. Sterile repackaging and compounding sites should build impact assessment of same-day and same-equipment batches into their sterility failure investigations.
Check points
Impact assessment of same-day and same-hood batches after a sterility failure
Protocols and reports for airflow visualization studies
Data basis for cleanroom cleaning intervals
Observation detail · 8 observations · From the source
Inspectors: Kara J Wright · Pushpa S Jayasekara · Jeremy T Dautrich
Observation 1
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Specifically, A. Your firm conducted Airflow Visualization (AFV) studies (smoke studies) for ISO 5 Laminar Flow Hood <Redacted B4> and Laminar Flow Hood <Redacted B4> under both static and dynamic conditions in August 2025 and February 2026. No formal study reports or supporting documentation were available for review for either study. The records lacked the following critical study elements: the type of smoke sources, the stated study purpose, targeted test locations, and personnel activities performed during dynamic conditions, real-time observations, and conclusions. Although video recordings of the AFV studies were captured, they were not accompanied by written protocols, contemporaneous documentation, or summary reports sufficient to contextualize, interpret, or substantiate the visual findings. B. Discrepancies were identified in the Airflow Visualization (AFV) records (videos) for ISO 5 Laminar Flow Hood <Redacted B4> and Laminar Flow Hood <Redacted B4> from studies completed in August 2025 and February 2026. The following deficiencies were observed: i. Incomplete Coverage of Critical Production Steps Across both August 2025 and February 2026 AFV studies, the dynamic airflow
Observation 2
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, Sterility test failure investigations for aseptically re-packaged Avastin 1.25 mg/0.05 mL were inadequate and failed to identify probable root causes. Since October 2025, the firm has rejected four batches due to sterility failures. Despite the rejection of these batches, other batches manufactured on the same day and in the same laminar flow hood in the table below were released without a scientifically sound justification or supporting data demonstrating adequate risk mitigation.
Observation 3
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
Specifically, A. Personnel and material flow into and out of the ISO 7 and ISO 8 classified areas occurs through a single shared pathway that passes directly through the visual inspection and labeling room. Gowning, degowning, and material transfer -including finished product exiting the cleanroom and incoming components entering -all traverse the same corridor used for labeling and visual inspection of previously released product, creating a convergence of traffic that is inconsistent with unidirectional flow principles. Specifically, operators completing shoe covers, head covers, masks, and hand washing in the nonclassified area must traverse this shared labeling room pathway to reach the ISO 8 entry door. Upon degowning, operators must similarly walk from ISO 7, through ISO 8, and through this same labeling room, where other staff are actively performing packaging, labeling, and visual inspection activities, to reach an outside corridor. No designated degowning area exists within the ISO 8 anteroom. Additionally, no physical or spatial separation exists within the ISO 8 anteroom to support or delineate a gowning zone, and operators were observed leaning against ISO 8 walls and
Observation 4
There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation.
Specifically, A. Your firm's cleaning procedure is inadequate. i. Your firm stated that only the ISO 5 laminar flow hood receives cleaning <Redacted B4>. However, your firm failed to clean the ISO 7 classified area <Redacted B4> leaving cleaning to the end of production for the day. ii. Your firm lacks scientifically established and data-supported cleaning intervals for the cleanroom. A review of cleaning records revealed a 49-day gap between the <Redacted B4> deep cleaning performed on 02/09/2026 and the subsequent cleaning on 03/30/2026. Furthermore, your firm acknowledged that scheduling cleaning on a <Redacted B4> basis -rather than at fixed intervals -could permit up to <Redacted B4> between cleaning events. Cleaning intervals of this duration, without scientific justification or validated hold-time data, present an unacceptable risk of microbial proliferation and environmental contamination in a classified cleanroom, potentially compromising the sterility and quality of drug products manufactured therein.
Observation 5
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Specifically, Your firm has not performed temperature mapping under the worst-case conditions for your critical equipment during equipment qualification.
Observation 6
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Specifically, Your firm continues to fail to provide a scientific rationale to support the established method and limits for subvisible particle testing of Avastin (bevacizumab) 1.75 mg/0.07 mL for intravitreal injection. Your firm releases this product using a subvisible particulate matter specification of <Redacted B4> particles/container at <Redacted B4> and <Redacted B4> particles/container at <Redacted B4>. <Redacted B4> lots associated with endophthalmitis adverse events were released using this particulate matter specification. This observation is a repeat observation from the previous FDA 483, List of Observations, issued on 11/04/2024.
Observation 7
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
Specifically, A. Your firm does not conduct periodic CGMP training for employees. B. Not all personnel receive basic training on the theory and practice of the Quality Management System and Good Manufacturing Practices, as required, per SOP-6 Training and Personnel, v2.0, effective September 30, 2025, Section 5.2.1. C. Your firm has not established training or qualification requirements to ensure that personnel responsible for reading and interpreting EM plate results are able to accurately enumerate and differentiate microbial growth and surface colonization.
Observation 8
Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.
Specifically, Your firm's product labels do not specify required storage temperature conditions, and the assigned <Redacted B4> beyond-use date (BUD) is not supported by stability testing. For example: your firm has failed to specify required storage temperature conditions on product labels, despite assigning a <Redacted B4> beyond-use date (BUD). For example, your firm stated that stability testing is not conducted for its non-sterile compounded products on the basis that the water activity content is less than <Redacted B4>%, with a <Redacted B4> BUD assigned at a controlled room temperature ot <Redacted B4>. However, all three non-sterile product labels reviewed during the inspection indicated only "room temperature," without further qualification or specification of the required temperature range, which is inconsistent with your firm's stated storage conditions.
FDA issued a Form 483 with four observations (Observations 1, 3, 4 and 6) to the outsourcing facility Imprimis NJOF LLC. They cover specifications for sterile ophthalmic products without scientific basis, unresolved root cause of fiber-like particles in moxifloxacin injectables, a visual inspection reinspection practice, and quality unit release without validated methods.
Published
2026-10-06
Document no.
fda483-195190
Site / company
Imprimis NJOF LLC · FEI 3013024146
Site · type
Outsourcing Facility · 483
Inspection date
08/18/2026
Key facts · Basis: official index plus supporting sources
Observation 1: release and stability specifications for multiple sterile ophthalmic products extend beyond compendial ranges without scientific justification
Observation 3: cellulose and other fiber-like material observed since 2023 in injectables made with moxifloxacin bulk powder; root cause not identified
Observation 4: batches failing 100% visual inspection can proceed to reinspection and AQL release before the investigation is complete (testing into compliance)
Observation 6: products released without validated impurity or degradant methods, with the exception of one product
Insight · Editorial insight
FDA characterized passing a batch through reinspection after a visual inspection failure as testing into compliance and expects the root-cause investigation to be complete first. Sterile injectable and ophthalmic sites should review the conditions under which failed batches may be reinspected and how particulates are characterized.
Check points
Investigation completion before reinspecting a failed visual inspection batch
Supplier-linked investigation of fiber-like particulates
Validation status of impurity and degradant methods in release testing
Observation detail · 4 observations · From the source
Inspectors: Simone E. Pitts · Lucila B. Nwatu · Annet R. Rajan
Observation 1
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Specifically, Release and stability specifications for <Redacted B4> potency, particle size distribution, uniformity of dose, and impurities for multiple sterile ophthalmic drug products are inadequate in the following respects: A. <Redacted B4> 1. <Redac t ed B4> Lack scientific basis for Finished Product Release Specifications Your firm was unable to provide scientific data or justification demonstrating that a <Redacted B4> release specification is appropriate for the sterile ophthalmic drug products listed below. The applicable compendial standards for the individual active ingredients contained in these products establish <Redacted B4> ranges that reflect the established chemical stability and ocular safety profiles of those ingredients. Your firm's specification extends beyond those established ranges on both the lower and/or upper ends, permitting release of drug product at <Redacted B4> values that would not conform to applicable compendial standards. For example, for the following sterile drug products: • DL003- Moxifloxacin Preservative-Free Solution Single-Use Intraocular Inje<!tion ( 4 mg/0.8 mL ( 5 mg/m L )), lbH•l Specification [(b) (4 )] (USP/NF Spec(fication ~b) (4
Observation 3
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, A. Your firm failed to conduct an adequate investigation to determine the root cause of cellulose, non-cellulose, and other fiber-like material that have been observed in the sterile injectable finished drug products containing APJ Moxifloxacin Hydrochloride bulk powder from 2023 until present day. The firm's root cause report VV-QUAL-02496 "Report for the presence of natural cellulose fibers in DM, DMK and Moxi 5" (Approved: 05/06/2025) was initiated to address a trend of an increase in the level of fibers detected in several injection products. The firm attributed the most probable root cause of the presence of natural cellulose fibers to the APT Moxifloxacin, specifically the use of the bulk drug substance; however, the exact mechanism of fiber generation from use of Moxifloxacin bulk drug substance has not been identified. The firm has not initiated an investigation with the current Moxifloxacin supplier to assess any changes to the manufacturing process that could potentially contribute to the fibers. The firm has initiated change controls to use a commercially available ophthalmic solution containing Moxitloxacin from a new supplier; however, your finn continues
Observation 4
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Specifically, Part A: Visual Inspection Automatic Reinspection Your firm's procedure VV-QUAL-00606, <Redacted B4> Visual Inspection, Version 24.0, Effective Date: 05/12/2026, specifies that when a batch fails 100% visual inspection by exceeding action levels for critical or major defects, a deviation is initiated, and a <Redacted B4> inspection of the remaining accepted units is conducted in tandem with the deviation investigation. Your firm's procedure permits a batch to proceed to <Redacted B4> inspection and, if passing, to tightened AQL inspection and potential release, before the deviation-investigation establishing the root cause of the initial 100% inspection failure has been completed. Proceeding to additional inspection passes prior to completing a thorough investigation of the initial failure does not constitute a thorough review of the batch faiture and represents testing into compliance. This practice does not provide assurance that the root cause of the initial inspection failure has been identified, evaluated, and corrected prior to batch release, and does not ensure that released units are free of the defects that caused the initial inspection failure. Part B: Lack o
Observation 6
The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
Specifically, Your firm's Quality Control Unit (QCU) has failed to exercise its responsibility to approve or reject drug products, procedures, and specifications, and to ensure that all established written procedures are followed, as evidenced by the following examples: A. The quality control unit approved and released drug products for distribution without impurity and degradant testing having been performed, despite the absence of validated test methods for the vast majority of products manufactured by the firm. With the exception of one product, [PMB Solution, relaunched July 2026], no validated impurity or degradant test method exists for any drug product manufactured and distributed by the firm. The QCU released and approved these batches for distributfon without this data, and without documented justification for the omission of a required quality attribute from the release testing program. B. The quality unit had the responsibility to ensure the Performance Qualification of the <Redacted B4> was scientifically sound and that all acceptance criteria were evaluated at the appropriate locations before approving the study. Approving a PQ that structurally excluded the confirmed
[Warning Letter · FDA]TCI Co., Ltd BioCosme PABP BRANCH — Missing release and identity testing
Evidence BFDASignal High · T3CGMP
FDA issued a Warning Letter citing four CGMP violations to TCI Co., Ltd. - BioCosme PABP BRANCH, an OTC drug contract manufacturer in Taiwan. The letter cites US distribution without finished-product assay testing, missing identity testing of components with unverified reliance on supplier COAs, inadequate process validation, and weak quality unit oversight.
Published
2026-10-06
Document no.
4ca9202786d6
Company / site
TCI Co., Ltd BioCosme PABP BRANCH
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 09/02/2026
Key facts · Basis: official index plus supporting sources
Violation 1: API assay not performed in finished-product release testing before US distribution (21 CFR 211.165(a))
Violation 2: no identity testing of incoming APIs and raw materials; reliance on supplier COAs without establishing their reliability (21 CFR 211.84(d)(1) and (d)(2))
Violations 3 and 4: inadequate process validation; process parameters changed without following change management (21 CFR 211.100(a), 211.22)
Follow-up: firm decided to let its drug registration expire; FDA must be notified before resuming, and a consultant qualified under 21 CFR 211.34 is recommended
Insight · Editorial insight
FDA held the contract manufacturer directly responsible for missing release tests regardless of agreements with product owners, and also cited the absence of a quality agreement. Contract manufacturing relationships should state test and specification responsibilities explicitly in the quality agreement.
Check points
Allocation of release testing and specification responsibilities in quality agreements
Periodic reliability verification for components accepted on supplier COAs
Change control applied when R&D staff adjust process parameters
Violation detail · 4 items · From the source
Violation 121 CFR 211.165(a)
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Violation 221 CFR 211.84(d)(1)
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Violation 321 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess (21 CFR 211.100(a)).
Violation 421 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]Pine Pharmaceuticals, LLC — Insanitary aseptic compounding
Evidence BFDASignal High · T3CGMP
FDA issued a Warning Letter to the 503B outsourcing facility Pine Pharmaceuticals, LLC for insanitary conditions and CGMP violations. The letter cites failure to disinfect materials moved from ISO 7 into the ISO 5 hood, no environmental monitoring of high-touch staging trays, inadequate particulate complaint investigation, and visual inspection defect classification problems.
Published
2026-10-06
Document no.
511a2f6e48e7
Company / site
Pine Pharmaceuticals, LLC
Issuing office / date
Center for Drug Evaluation and Research (CDER) · 08/07/2026
Key facts · Basis: official index plus supporting sources
Insanitary conditions: materials, equipment and hands not sanitized before entering the ISO 5 hood; sleeves extended into the ISO 5 area without sanitizing
Environmental monitoring: high-touch staging trays used for final container closures not monitored
Repeat: aseptic technique deficiencies follow FDA inspections in May 2021, September 2023 and September 2024
Insight · Editorial insight
FDA found a 'no product impact' conclusion based on passing environmental monitoring and sterility results scientifically insufficient. Aseptic compounding and filling sites should assess operator technique deviations from a process control perspective rather than from test results.
Check points
Records of material disinfection when moving from ISO 7 to ISO 5
Inclusion of handled surfaces such as staging trays in environmental monitoring
SOP definitions for visual inspection defect categories
Shown in the original Korean: 1 value in this table.
Original text
품질부적합
Key facts · Basis: official source record kept by the collector
Reason: quality nonconformity
Action: 3-month suspension of manufacturing of the product
Legal basis: Pharmaceutical Affairs Act Article 62 and Article 76
Insight · Editorial insight
A single quality nonconformity led to a product-level manufacturing suspension. Herbal and botanical manufacturers should reconfirm, product by product, the test results and conformity basis used at release.
Check points
Release test items and conformity basis for each product
Impact assessment of products sharing the same raw material after a nonconformity
Evidence AMFDSSignal Med · T2💊 Small moleculeAdministrative action
MFDS imposed a fine in lieu of a 15-day sales suspension on an importer because part of the product name was not stated on the immediate container of an imported human placenta extract injection.
Published
2026-09-28
Document no.
admin-2026007296
Companies
(주)한국멜스몬
Action
○ 수입 의약품 ‘멜스몬주(자하거추출물)’에 대한 판매업무정지 15일 처분을 갈음한 과징금 2,325,000원 부과
Shown in the original Korean: 1 value in this table.
Original text
- 수입 의약품 ‘멜스몬주(자하거추출물)’ 품목을 수입·판매함에 있어, 해당 의약품을 직접 담는 용기에 ‘제품명 중 일부 내용’을 기재하지 않은 사실이 있음.
Key facts · Basis: official source record kept by the collector
Violation: part of the product name not stated on the immediate container
Action: fine of 2,325,000 won in lieu of a 15-day sales suspension
A labeling violation on an imported product led to a fine in lieu of a sales suspension, showing that the importer's label review is itself subject to enforcement. Importers should verify at receipt that immediate container labeling matches the full approved product name.
Check points
Receipt check that immediate container labels match the approved product name
Text approval process with the foreign manufacturer when labeling changes
[Recall / sales suspension · MFDS](주)현진제약 — Identification test recall
Evidence AMFDSSignal High · T3▫️ OtherRecall
MFDS ordered a mandatory recall of a herbal medicine product over the identification test.
Published
2026-10-08
Document no.
recall-4204db70bc4c
Companies
(주)현진제약
Product
현진골쇄보
Original text
확인시험
Key facts · Basis: official source record kept by the collector
Reason: identification test
Type: mandatory recall (order dated 20261008)
Product: a herbal medicine product
Insight · Editorial insight
Identification test failures can generally be associated with the origin of the raw material or admixture, which puts raw material receipt control in focus. Herbal manufacturers should review identification testing at receipt and supplier control records.
Check points
Identification testing records for incoming herbal materials
MFDS ordered a mandatory recall of a herbal medicine product for nonconformity in description.
Published
2026-10-08
Document no.
recall-4663bf86acaa
Companies
주식회사올본
Product
올본부자
Original text
성상 부적합
Key facts · Basis: official source record kept by the collector
Reason: nonconformity in description
Type: mandatory recall (order dated 20261008)
Product: a herbal medicine product
Insight · Editorial insight
Description failures concern basic attributes such as appearance, colour or odour and can be associated with raw material quality or storage conditions. Herbal manufacturers should check how specific their description criteria are and how storage conditions are controlled.
Check points
Description criteria and reference samples
Storage condition records for raw materials and products
Pesticide residue failures can be associated with contamination at cultivation carried into the raw material, making the scope of incoming testing the key question. Herbal manufacturers should review pesticide residue test items for incoming materials and supplier history.
Check points
Pesticide residue test items for incoming materials, including procymidone
[Recall / sales suspension · MFDS](주)성원제약 1.이안덴탈캄센시티브치약 외 1품목 — Toothpaste recall on quality concern
Evidence AMFDSSignal High · T3▫️ OtherRecall
A manufacturer is voluntarily recalling two toothpaste products over a possible quality nonconformity. It is a single recall covering two products for the same reason.
Published
2026-10-07
Document no.
recall-5c1b0c75c945
Companies
(주)성원제약
Product
1.이안덴탈캄센시티브치약 외 1품목
All 2 products
1.이안덴탈캄센시티브치약
1.리브러쉬브라이트닝인텐스치약
Original text · representative case
품질부적합 우려
Key facts · Basis: official source record kept by the collector
Reason: possible quality nonconformity
Type: voluntary recall by the company (order dated 20261007)
Scope: two products recalled together for the same reason
Insight · Editorial insight
This is a precautionary recall citing a concern rather than a specific failed attribute, so the cause cannot be identified from the notice. A recall of several products from one manufacturer may reflect a shared material or process, so products using common materials should be checked together.
Check points
Impact scope across products sharing materials or processes
Records supporting the precautionary recall decision
Evidence AMFDSSignal High · T3💊 Small moleculeRecall
A manufacturer is voluntarily recalling a tablet product as a precaution after an off-odour was found in the product.
Published
2026-10-07
Document no.
recall-c191f480bcb5
Companies
(주)한풍제약
Product
페인싹트리플정
Original text
제품 내 이취로 인한 사전 예방 차원의 영업자 자진 회수
Key facts · Basis: official source record kept by the collector
Reason: precautionary voluntary recall due to an off-odour in the product
Type: voluntary recall (order dated 20261007)
Product: a tablet product
Insight · Editorial insight
An off-odour in tablets can generally be associated with degradation of the active or excipients or with packaging materials, so stability and packaging suitability come under review. Tablet manufacturers should check whether odour complaints trigger review of stability and retained samples and packaging history.
Check points
Review of stability and retained samples after odour complaints
Carvedilol 25 mg tablets from several companies were recalled the same week for an impurity out of specification, raising the possibility of a shared API or supply chain factor. Manufacturers handling carvedilol should check their API source and impurity trend data.
Check points
Overlap of carvedilol API suppliers
Impurity result trends, including stability
Recall detail · From the source · Health Canada
Active ingredient · 25 MGDosage form · Tablet
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.
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada recalled Carvedilol 25 MG tablets from Pro Doc as out-of-specification for an impurity (Type II).
Published
2026-10-06
Document no.
hc-82726
Companies
Pro Doc
Product
Carvedilol
Class
Type II
Original text and translation
Product quality
Key facts · Basis: official source record kept by the collector
Reason: product quality (impurity out of specification)
Recall class: Type II
Product: Carvedilol 25 MG tablets
Insight · Editorial insight
A Pro Doc product was also recalled at the same strength for the same reason, so the question is whether the carvedilol impurity issue extends beyond a single site. For contract or imported carvedilol products, manufacturer and API lot information should be checked to judge impact.
Check points
Identification of the manufacturer for contract or imported carvedilol
Comparison of impurity results by API lot
Recall detail · From the source · Health Canada
Active ingredient · 25 MGDosage form · Tablet
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]Pendopharm — Diphenhydramine impurity recall
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada recalled PDP-DIPHENHYDRAMINE 25 MG capsules from Pendopharm as out-of-specification for an impurity (Type II).
Published
2026-10-05
Document no.
hc-82720
Companies
Pendopharm
Product
PDP-DIPHENHYDRAMINE
Class
Type II
Original text and translation
Product quality
Key facts · Basis: official source record kept by the collector
Reason: product quality (impurity out of specification)
Recall class: Type II
Product: PDP-DIPHENHYDRAMINE 25 MG capsules
Insight · Editorial insight
This is an impurity out-of-specification recall for diphenhydramine capsules; in capsules, interaction with the shell as well as the API can contribute to impurities. Capsule manufacturers should check that impurity investigations cover both the API and the shell.
Check points
Scope of impurity investigations (API and capsule shell)
Impurity trends during stability
Recall detail · From the source · Health Canada
Active ingredient · 25 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.
[Recall (Health Canada) · Health Canada]Sanis — Carvedilol impurity recall
Evidence AHealth CanadaSignal Med · T2💊 Small moleculeRecall
Health Canada recalled CARVEDILOL 25 MG tablets from Sanis as out-of-specification for an impurity (Type II).
Published
2026-10-05
Document no.
hc-82722
Companies
Sanis
Product
CARVEDILOL
Class
Type II
Original text and translation
Product quality
Key facts · Basis: official source record kept by the collector
Reason: product quality (impurity out of specification)
Recall class: Type II
Product: CARVEDILOL 25 MG tablets
Insight · Editorial insight
With the Sanis product, carvedilol 25 mg recalls continued through the same week. If the impurity was found after release, impurity growth during stability should be examined as well.
Check points
Impurity growth trends in stability studies
Recall decision procedure for post-release OOS results
Recall detail · From the source · Health Canada
Active ingredient · 25 MGDosage form · Tablet
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.
Evidence AMHRASignal Med · T2💊 Small moleculeRecall
MHRA announced a Class 3 recall of specific batches of MOVICOL Plain 13.7g powder for oral solution from Norgine Limited. Some units contain incorrect amounts of the active ingredients, and the batches are recalled as a precaution.
Published
2026-10-05
Document no.
3c24cd12096b
Class
Class 3
Companies
Norgine Limited
Original text and translation
Norgine Limited is recalling specific batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients.
Key facts · Basis: official source record kept by the collector
Reason: incorrect amounts of active ingredients in some units
Recall class: Class 3
Product: MOVICOL Plain 13.7g powder for oral solution (EL(26)A/41)
Insight · Editorial insight
In unit-dose powders, incorrect active content per unit can generally be associated with filling or blend uniformity. Sachet powder and granule products should review fill weight control and how content uniformity is confirmed.
Check points
In-process fill weight control for sachet powders
Sample size and frequency for content uniformity testing
Recall detail · From the source · MHRA
Full alert (Drug Alert)
Original · MHRA
DMRC reference number DMRC - 40129134 Marketing Authorisation Holder Norgine Limited Medicine Details MOVICOL Plain 13.7g powder for oral solution PL: 20142/0004 Active Ingredients: macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride SNOMED code: 11588511000001108 GTIN: 05012748615328 Affected Lot Batch Numbers Batch No. Expiry Date Pack Size First Distributed 487069 28/02/2029 30 05/06/2026 474919 31/08/2028 30 07/11/2025 Background Norgine Limited is recalling the above batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients. Advice for Healthcare Professionals: Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. Advice for Patients: No further action is required by patients as this recall is being undertaken at retail and wholesaler levels. The recall is being undertaken out of an abundance of caution, patients in possession of this batch of product may continue to take this medicine. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme . Additional information: For all medical information enquiries and information on this product, please email [email protected] , or telephone +44 (0) 1895 826606. For stock control enquiries please email [email protected] , or telephone +44 (0) 1895 826600. Recipients of this Medicines Recall 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 3 Medicines Recall: Norgine Limited, MOVICOL Plain 13.7g powder for oral solution, EL(26)A/41
Sunscreens are regulated as OTC drugs in the US, so cGMP deviations are a recall reason even for cosmetic-style products. Exporters of sunscreen to the US should confirm the scope of drug cGMP requirements that apply.
Check points
Application of OTC drug cGMP to sunscreens exported to the US
cGMP audit records for contract manufacturers
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-08-08FDA classification · 2026-09-18FDA published · 2026-09-30
FDA classified as Class II a recall of nine products from Sterling Pharmaceutical Services LLC, including AvKare carboxymethylcellulose sodium ophthalmic solution 0.5%, for lack of assurance of sterility.
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38
Original text and translation · representative case
Lack of Assurance of Sterility
Key facts · Basis: official source record kept by the collector
Reason: Lack of Assurance of Sterility
Recall class: Class II
Scope: nine products recalled together for the same reason (lead item: AvKare carboxymethylcellulose sodium ophthalmic solution 0.5%)
Insight · Editorial insight
Multiple eye drop products from one contract manufacturer recalled for the same sterility assurance reason may point to a process or facility-level issue. Companies outsourcing eye drops should check the contractor's aseptic process validation and environmental monitoring records.
Check points
Aseptic process validation status at the eye drop contractor
Environmental monitoring excursion history at the contractor
Recall detail · From the source · OpenFDA · Based on the representative product
This card groups 9 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 · 2026-08-20FDA classification · 2026-09-21FDA published · 2026-09-30
[Recall · FDA]Amneal Pharmaceuticals of New York, LLC — Prefilled pen may lack drug
Evidence AFDASignal Med · T2💊 Small moleculeRecall
FDA classified the recall of exenatide injection prefilled pens from Amneal Pharmaceuticals of New York, LLC as Class II for a defective delivery system (possibility of no medication in the pen).
Published
2026-09-30
Document no.
D-0868-2026
Companies
Amneal Pharmaceuticals of New York, LLC
Product
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta…
Class
Class II
Original text and translation
Defective Delivery System: Possibility of no medication in the prefilled pen.
Key facts · Basis: official source record kept by the collector
Reason: defective delivery system; possibility of no medication in the prefilled pen
Recall class: Class II
Product: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL prefilled pen
Insight · Editorial insight
In drug-device combination products, the possibility of an empty pen can be associated with gaps in fill or assembly inspection. Prefilled pen and syringe products should review fill verification and post-assembly inspection.
Check points
Method for 100% fill verification of prefilled pens
Post-assembly functional and visual inspection criteria
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiatedFirst notified · Letter
Status
Recall initiated · 2026-08-28FDA classification · 2026-09-22FDA published · 2026-09-30
FDA classified as Class II a recall of two products from Insight Pharmaceuticals LLC, including Clear Eyes Redness Relief eye drops, for lack of assurance of sterility.
Published
2026-09-30
Document no.
D-0870-2026
Companies
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Product
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15 외 1품목
Class
Class II
All 2 products
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
Original text and translation · representative case
Lack of Assurance of Sterility
Key facts · Basis: official source record kept by the collector
Reason: Lack of Assurance of Sterility
Recall class: Class II
Scope: two products recalled together for the same reason (lead item: Clear Eyes Redness Relief, glycerin 0.25%, naphazoline hydrochloride 0.012%)
Insight · Editorial insight
A branded OTC eye drop was also recalled for lack of sterility assurance, showing that the sterility basis of multi-dose eye drop containers is an enforcement target. Companies outsourcing OTC eye drops should check aseptic filling and container closure integrity data.
Evidence AFDASignal Med · T2💊 Small moleculeRecall
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Nystatin Cream (15 g tube) made by Taro Pharmaceutical Industries Ltd. for failed stability specifications. FDA has not yet classified the recall.
Published
2026-09-23
Document no.
N/A
Companies
SUN PHARMACEUTICAL INDUSTRIES INC
Product
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd.
Class
Not Yet Classified
Original text and translation
Failed Stability Specifications
Key facts · Basis: official source record kept by the collector
Reason: Failed Stability Specifications
Recall class: Not Yet Classified
Product: Nystatin Cream, USP, 15 g tube (made by Taro Pharmaceutical Industries Ltd.)
Insight · Editorial insight
A stability failure means the basis for quality through shelf life has been undermined, putting OOS and OOT management in ongoing stability studies directly in focus. Semi-solid manufacturers should check the criteria by which stability OOT trends lead to recall decisions.
Check points
OOT trend management in ongoing stability studies
Impact assessment of marketed lots after a stability OOS
Recall detail · From the source · OpenFDA
Status · OngoingVoluntary: Firm initiated
Status
Recall initiated · 2026-09-14FDA published · 2026-09-23
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