Procedure

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): Procedures are not established, written and followed to prevent microbiological contamination

Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:

On July 11, 2023, two (2) of

29/02/2024

Microbiology FDA 483 (Dr. Reddy’s Laboratories): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established

Specifically, accuracy, sensitivity, specificity, and reproducibility of TAMC (Toral Aerobic Microbial Count) test used to routinely test *** for the

27/02/2024

Microbiology FDA 483 (Dr. Reddy’s Laboratories): Appropriate written specifications for acceptance are deficient

Specifically, determination of conformance to written specifications are deficient for TAMC (Total Aerobic Microbial Count) test and TYMC (Total Yeast

27/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Procedures designed to prevent microbiological contamination not include adequate validation of the aseptic process

(1) Smoke studies do not show demonstrate appropriate airflow:

(a) Smoke studies for Line *** and Line *** show turbulent

24/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Laboratory records not complete and not assured compliance with SOP & Standards

Microbiologists responsible for collecting environmental monitoring and personnel monitoring samples confirmed they do not collect all samples due to workload.

23/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Procedures are not established, written and followed to prevent microbiological contamination

Specifically, during setup, aseptic filling, transfer of equipment and components, and line disassembly/cleaning in the Grade A area of ***

23/02/2024

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

Environmental monitoring and personnel monitoring data is not reliable because of the materials used to conduct tests.

22/02/2024

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 (Central Admixture Pharmacy): Procedures are not established, written and followed to prevent microbiological contamination

Microbiology FDA 483 (Dr. Reddy’s Laboratories): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established

Microbiology FDA 483 (Dr. Reddy’s Laboratories): Appropriate written specifications for acceptance are deficient

Microbiology FDA 483 (Kilitch Healthcare): Procedures designed to prevent microbiological contamination not include adequate validation of the aseptic process

Microbiology FDA 483 (Kilitch Healthcare): Laboratory records not complete and not assured compliance with SOP & Standards

Microbiology FDA 483 (Kilitch Healthcare): Procedures are not established, written and followed to prevent microbiological contamination

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

Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Eugia Steriles): Control procedures are not established which validate the performance of those manufacturing processes

Microbiology FDA 483 (Eugia Steriles): Input to and output from the computer and records or data are not checked for accuracy

Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed

Microbiology FDA 483 (Zydus Lifesciences): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Zydus Lifesciences): Buildings used in the manufacturing of a drug product are not maintained in a good state of repair

Microbiology FDA 483 (Zydus Lifesciences): Procedures designed to prevent microbiological contamination are not written and followed

Microbiology FDA 483 (Zydus Lifesciences): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Cipla Limited): Failure to clean and maintain equipment and utensils to prevent contamination

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