FDA 483 - Lupin Limited - March 29, 2023

On March 29, 2023, the FDA issued a Form 483 to Lupin Limited, a drug manufacturer located in Pithampur, India, following an inspection from March 21-29, 2023. The inspection revealed ten observations regarding deviations from Good Manufacturing Practices (GMP).

Key observations include: 1. **Inadequate Investigations:** Investigations into batch failures (e.g., an Out-of-Specification (OOS) stability result for a solution batch) did not extend to other potentially associated drug products, and root causes like surface imperfections were not identified during initial inspection. 2. **Failure to Review Discrepancies (Repeat Observation):** The firm failed to document and investigate deviations/equipment failures in batch records, including critical process equipment breakdowns, for US-marketed products. 3. **Deficient Complaint Investigations (Repeat Observation):** Repeated market complaints for foreign tablets/capsules in US-marketed products were concluded as "unconfirmed" without effective recurrence prevention, despite some foreign tablets being manufactured at the facility. 4. **Inadequate Employee Training (Repeat Observation):** Personnel failed to complete assigned training by due dates, and ongoing CGMP training for contracted personnel was not provided. 5. **Quality Control Unit Deficiencies:** The firm failed to adequately classify and assess a "Minor" change control for a Windows operating system upgrade that required revalidation, and