Warning Letter Cipla Ltd Pithampur Unit (17/11/2023)

 

The recently warning letter issued to CGMP Violation from USFDA Inspection of  Cipla Ltd. Pithampur (MP) manufacturing site from 06/02/23 to 17/02/2023

Detail Description Click

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your 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 or not the batch has already been distributed (21 CFR 211.192).

2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

3. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).

4. Repeat Observations at Multiple Sites

5. Field Alert Reporting Violations

More Detail Click the Link :-

.