FDA 483 - Dr. Reddy’s Laboratories Limited - July 18, 2025

An FDA inspection of Dr. Reddy's Laboratories Limited, a sterile drug manufacturer in Pydibhimavaram, India, revealed significant deficiencies across multiple systems. Observations included inadequate procedures for preventing microbiological contamination, insufficient aseptic process validation, and failures in drug product release testing. The firm also demonstrated issues with equipment qualification, in-process material testing, quality control unit review of batch records, and a systemic failure to thoroughly review and ensure the effectiveness of corrective and preventive actions for deviations and out-of-specification results.