# FDA 483 - Lupin Limited - March 29, 2023

Source: https://www.keypedia.com/records/483/lupin-limited/cb2a61fc-450e-46a8-b38d-d73ceb8fec78

> FDA 483 for Lupin Limited on March 29, 2023. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2023-03-29
- Summary: 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

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- [483 - 2023-03-29](https://www.keypedia.com/records/483/lupin-limited/221b0dd1-0d74-4087-b84d-d18d441c876e)

## Related Officers

- [Eileen A. Luu](https://www.keypedia.com/people/eileen-a-luu/14e0fde2-6f5f-4611-90f5-d0fb1c18a8ab)
- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/lupin-limited/8707ad63-3e60-4c11-9138-77be2a49865c