Zydus Lifesciences Limited – FDA 483

An FDA inspection of Zydus Lifesciences Limited, a drug substance manufacturer in Changodar, India, revealed significant deficiencies across multiple quality systems. Observations included inadequate process validation for API intermediates, insufficient investigations into out-of-specification results, and unverified or unvalidated test methods. Additionally, the firm's change control system, batch production records, and laboratory control records were found to be incomplete or inadequate, indicating a lack of robust quality oversight.