FDA 483 - Dr. Reddy's Laboratories Ltd. - February 08, 2019

The FDA issued a Form 483 to Dr. Reddy's Laboratories Ltd. following an inspection conducted from January 30 to February 8, 2019. The inspection revealed significant deviations from Current Good Manufacturing Practices (CGMP). Key observations included deficiencies in the quality system, specifically inadequate procedures and follow-up for handling product complaints and a lack of thoroughness in investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) results. The Quality Control unit also lacked proper authority to ensure all errors were fully investigated and to reject non-compliant drug products. Recurring issues were noted regarding inadequate controls over computer systems, failing to ensure changes by authorized personnel and maintaining data integrity. Procedures for the quality control unit were often not written, not followed, or lacked sufficient detail, impacting aspects like OOS reporting and reserve sample inspections. Furthermore, master production and control records lacked adequate sampling and testing procedures, and operators were found overriding alarms without proper documentation or investigation. Reserve drug product samples were deemed not representative of entire batches. Facility issues included inadequate laboratory conditions, with temperatures exceeding limits for drug product storage and glassware usage, and insufficient space to prevent cross-contamination between different drug product types. Drains also lacked appropriate devices to prevent back-siphonage. Dr. Reddy's Laboratories Ltd. is required to provide a comprehensive response detailing corrective actions to address these observed deficiencies and ensure compliance with regulatory standards.