FDA 483 - Cipla Limited - July 01, 2022

This FDA Form 483 document details observations made during an inspection of a drug manufacturing facility. The inspection, which included a review of cleaning validation, identified two primary violations.

Firstly, equipment and utensils were not cleaned and maintained at appropriate intervals to prevent contamination. Specifically, during a review of cleaning validation report CUR01 for REDACTED batches, the surface area of each equipment was documented. However, when the investigator requested raw data for surface area calculations for equipment such as REDACTED Accessories and the Packing Machine, the Site Quality Assurance Head stated that no such raw data existed. This lack of raw data meant there was no evidence that swab samples, presumably taken for cleaning validation, were actually analyzed.

Secondly, samples taken of drug products for determination of conformance to written specifications were not properly identified.

These observations indicate deficiencies in the facility's quality system regarding equipment cleaning validation and sample identification, potentially impacting the safety, identity, strength, quality, and purity of drug products.