FDA 483 - Cipla Limited - July 01, 2022

An FDA inspection of Cipla Limited, a drug manufacturer in Indore SEZ, India, from June 27 to July 1, 2022, identified two significant observations. The firm failed to maintain raw data for surface area calculations critical for cleaning validation, raising concerns about the integrity of swab sample analysis. Additionally, drug product samples for stability testing were not properly identified, with discrepancies noted between physical inventory and reconciliation data.