FDA 483 - Cipla Limited - January 28, 2019

Cipla Limited in Verna, India, was inspected by the FDA from January 21-28, 2019, regarding its manufacturing of drug products. The inspection revealed significant deficiencies across multiple systems, including inadequate quality control investigations, poor aseptic practices, incomplete master production records, unsuitable equipment design, insufficient drug product testing and release procedures, and an incomplete stability program. These observations indicate a broad range of issues impacting product quality and regulatory compliance.