FDA 483 - Cipla Ltd. - May 26, 2025

Cipla Ltd., an API manufacturer in Bangalore, India, was cited for inadequate cGMP controls during an FDA inspection. The firm failed to extend investigations into related deviations, lab incidents, and other quality events, leading to a lack of trending for recurring issues. Additionally, the inspection noted numerous failed batches and concerns regarding the accuracy and reproducibility of QC laboratory test methods.