FDA 483 - Cipla Limited - February 17, 2023

This FDA Form 483 document outlines several significant observations made during an inspection. The facility failed to thoroughly review unexplained discrepancies and instances where batches or components did not meet specifications, even if distributed. Procedures to prevent microbiological contamination of sterile drug products were not established, written, or followed. The aseptic processing areas had deficient environmental monitoring systems.

Furthermore, appropriate controls were not exercised over computer systems to ensure that changes to master production and control records were made only by authorized personnel. Procedures for handling written and oral drug product complaints were deficiently written or followed. A Field Alert Report was not submitted within the required timeframe after receiving information about a distributed batch failing to meet specifications. The responsibilities and procedures of the quality control unit were not fully followed. Lastly, laboratory records lacked complete data from all necessary tests, examinations, and assays required to ensure compliance with established specifications and standards. These observations indicate deficiencies across quality control, manufacturing, data integrity, and regulatory reporting.