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2026-10-19FDA 483Mylan Laboratories LimitedStability and storage · Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Complaint and recall handling · Quality unit oversightThe written stability testing program is not followed. 2026-10-19FDA 483Zen Chemicals Pvt. LtdCleaning validation · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controlsEmployees are not trained in cleaning procedures. 2026-10-19FDA 483GPC Medical LimitedOther quality system · Laboratory and QC controlsProcedures for acceptance ofin-process product have not been adequately established. 2026-10-19FDA 483Perrigo New York, Inc.Contamination control · Equipment and facilitySeparate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. 2026-10-19FDA 483Centrient Pharmaceuticals India Private LimitedEquipment and facility · Material and supplier control · Cleaning validationFailure to have the procedures and processes necessary to ensure the API and intermediates manufactured at your facility meet established specifications for qua… 2026-10-19FDA 483Almon Healthcare Private LimitedQuality unit oversight · Material and supplier control · Other quality system · Cleaning validation · Computer system validation · Stability and storage · Equipment and facility · Laboratory and QC controlsFailure of your quality unit to exercise its responsibility to ensure the active pharmaceutical ingredient (API) and intermediates manufactured at your facility… 2026-10-19FDA 483Greer Laboratories, Inc.Equipment and facility · Quality unit oversight · Other quality system · Process validationWritten procedures are not followed for the cleaning and maintenance of equipment, including[~ | used in them—_e =. 2026-10-19FDA 483DiagastDocumentation and records · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality systemThe written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was repo… 2026-10-19FDA 483Kansas State Veterinary Diagnostic LaboratoryProcess validation · Laboratory and QC controls · Equipment and facility · Documentation and recordsWritten production and process control procedures are not followed in the execution of production and process control functions. 2026-10-19FDA 483Dendreon Pharmaceuticals LLCDocumentation and records · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system · Quality unit oversight · Process validation · Laboratory and QC controlsThe batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing an… 2026-10-19FDA 483Eugia Pharma Specialities LimitedQuality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Process validation · Equipment and facilityThe responsibilities and procedures applicable to the Quality Unit are not fully followed. 2026-10-19FDA 483Loba biotech GmbHDeviation, CAPA, and investigation · Equipment and facility · Training and personnel · Validation and qualification · Other quality systemYou failed to take adequate corrective action preventative action (CAPA) for a manufacturing system, resolution of an aberrant condition in a timely manner. 2026-10-16EU GMP NCR (EudraGMDP)Glukem Biocare Private LimitedDocumentation and recordsThe inspection resulted in a critical deficiency related to contamination risk in the Fluid Bed Coating (FBC) equipment due to an observed pool of liquid and re… 2026-10-13FDA Warning LetterEurofins SF Analytical Laboratories, Inc.Deviation, CAPA, and investigation · Laboratory and QC controls · Quality unit oversightYour 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… 2026-10-13FDA Warning LetterLovelace Biomedical Research InstituteOther quality systemThe final study report did not include descriptions of the following dosing issues, which were recorded on the raw data forms for Inhalation Exposure and PK Blo… 2026-10-13FDA Warning LetterHanlim Pharm Co., Ltd.Aseptic processing and sterility assurance · Quality unit oversight · Process validationYour firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting t… 2026-10-13FDA Warning LetterJiangmen Shuizirun Sanitary Articles Co., Ltd.Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier controlYour firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established sp… 2026-10-13FDA Warning LetterSCA Pharmaceuticals, LLCAseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Equipment and facilityYour firm failed to perform adequate airflow visualization studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Your ai… 2026-10-08EU GMP NCR (EudraGMDP)Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingData integrityThe 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 produ… 2026-10-07EU GMP NCR (EudraGMDP)Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingData integrityThe 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 produ… 2026-10-07EU GMP NCR (EudraGMDP)Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingData integrityThe 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 produ… 2026-10-07EU GMP NCR (EudraGMDP)Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingData integrityThe 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 produ… 2026-10-06FDA Warning LetterTCI Co., Ltd BioCosme PABP BRANCHQuality unit oversight · Material and supplier control · Laboratory and QC controls · Process validationYour firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established spe… 2026-10-06FDA Warning LetterPine Pharmaceuticals, LLCDocumentation and records · Aseptic processing and sterility assurance · Complaint and recall handling · Validation and qualification · Deviation, CAPA, and investigation · Other quality system · Process validation · Training and personnelYour firm failed to determine actual yield and percentages of theoretical yield at the conclusion of each appropriate phase of manufacturing, processing, packag…