Specifications

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 (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