Test Procedure (SOP)

Microbiology FDA 483 (Zydus Lifesciences): Established sampling plans and test procedures are not followed

Procedures 0317-SOP-QC-00193 “Sampling and Testing procedure of *** and 0317-SOP- C-00118 “Quality monitoring of *** System” were not followed for

30/04/2024

Microbiology FDA 483 (Precision Equine LLC): Procedures to prevent microbiological contamination are not established; written and followed

Your environmental monitoring (EM) of the ISO 5 Laminar Airflow Hood (LAFH) in Sterile Non-Hazardous Drug Suite and the ISO

26/04/2024

Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Your QC Microbiology laboratory has no equipment usage logbook or any other document that records incubator usage details for a

19/04/2024

Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, test procedures

The Microbial Limit Testing performed on *** Tablets Batch *** on long term stability conditions at time point 35 months

09/04/2024

Microbiology FDA 483 (Catalent Indiana): Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures

Specifically, there is a failure to validate the endotoxin sample storage of drug products under project code *** at ***

23/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for cleaning and disinfection

Brown substance was observed inside your grey reusable spray bottles filled with the *** solution. On July 11, 2023, observed

02/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for monitoring environmental conditions

Your aseptic operators disinfect ISO 5 surfaces prior to environmental monitoring sample collection. This practice can yield false-negative results. For

02/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Results of stability testing are not used in determining appropriate storage conditions and expiration dates

Your *** stability program does not include sterility or endotoxin testing at the endpoint. Your firm only tests sterility and

01/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented

Your firm’s Quality Unit failed to perform a method transfer of your sterility test method used for release of drug

01/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Not include the establishment of scientifically sound and appropriate specifications

Your firm failed to provide scientific evidence that endotoxin specification for products intended for epidural administration is adequate. Specifically,

29/02/2024

Microbiology FDA 483 (Zydus Lifesciences): Established sampling plans and test procedures are not followed

Microbiology FDA 483 (Precision Equine LLC): Procedures to prevent microbiological contamination are not established; written and followed

Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, test procedures

Microbiology FDA 483 (Catalent Indiana): Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for cleaning and disinfection

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for monitoring environmental conditions

Microbiology FDA 483 (Central Admixture Pharmacy): Results of stability testing are not used in determining appropriate storage conditions and expiration dates

Microbiology FDA 483 (Central Admixture Pharmacy): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented

Microbiology FDA 483 (Central Admixture Pharmacy): Not include the establishment of scientifically sound and appropriate specifications

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

Microbiology FDA 483 (Jubilant Radiopharmacies): The movement of first air in the ISO 5 area is blocked or disrupted

Microbiology FDA 483 (Jubilant Radiopharmacies): Personnel were observed performing aseptic processing outside of an ISO 5 area

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations

Microbiology FDA 483 (Eugia Pharma Specialities): 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

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination sterile drug product are not established and followed