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

Dr. Reddy's Laboratories Limited received an FDA Form 483 following an inspection from July 10-18, 2025, at their sterile drug manufacturing facility in Pydibhimavaram, India. The inspection highlighted significant deficiencies across production and quality systems, indicating non-conformance with Current Good Manufacturing Practices.

Key production issues included inadequate procedures to prevent microbiological contamination, such as allowing non-sterile cleaning agents and lacking clarity on sanitization agent sterility in Grade A environments. Aseptic process validation was found deficient due to poor visualization in smoke studies, potentially compromising sterile product protection. Drug product testing and release processes were inadequate, specifically visual inspection for particulate matter, where vials were not rotated sufficiently, potentially missing defects. Additionally, compounding equipment capacity was not adequately qualified, raising concerns about potential carryover, and in-process material testing lacked assurance for critical parameter measurement, impacting distributed batches.

Regarding the quality system, the FDA observed failures in record review and approval by the quality control unit before batch release. This included undocumented secondary verifications of microbial counts and missing raw data in batch reports. The firm also failed to thoroughly investigate discrepancies and ensure the effectiveness of corrective and preventive actions (CAPAs). Examples cited include an unproven repeatable cleaning process for aseptic areas, recurring Out-of-Specification results with insufficient preventive measures, and CAPAs for cracked vials and critical rejects that were not fully implemented into standard operating procedures or batch manufacturing records. Dr. Reddy's is required to provide comprehensive responses to address these observations.