# FDA 483 - Lupin Limited - March 29, 2023

Source: https://www.keypedia.com/records/483/lupin-limited/f06831df-7020-4ea9-8e5d-b47ca946e828

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

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2023-03-29
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations from an inspection of a pharmaceutical manufacturing facility.

**Facility and Operations:** The document refers to a facility of Lupin Limited, mentioning specific areas like the warehouse, QC Batch, Inspection area, manufacturing and packaging areas, Building, and a filling line room. Products include Solution Batch, Capsules, Tablets (USP mg, USP 1g), and other US-marketed drug products.

**Violations and Observations:**

*   **Observation 1:** Investigations into out-of-specification (OOS) results for a Solution Batch (9-Month Long Term stability study) were inadequate. An OOS result for a test was found, but the investigation did not extend to other potentially affected drug products. The root cause identified (surface imperfections) was not reported during initial incoming material inspection.
*   **Observation 2 (Repeat):** The firm failed to thoroughly review unexplained discrepancies and OOS results.
    *   **A.** Deviations/equipment failures during manufacturing and packaging were not consistently documented in batch records, investigated, or subjected to risk assessments and CAPAs. Out of 1695 breakdown notifications (Jan 2019-Mar 2023), only 41 were investigated.
    *   **B.** Deviation investigations were not thorough, and appropriate actions were not taken. Examples include:
        *   A foreign-filled capsule found in a Capsule Batch, supplied by

## Related Documents

- [483 - 2017-05-19](https://www.keypedia.com/records/483/lupin-limited/77cdb6c3-8757-4eda-8414-0486dd545093)
- [483 - 2019-01-25](https://www.keypedia.com/records/483/lupin-limited/70b65220-35c3-48b6-89b1-0be80e795312)
- [483 - 2023-03-29](https://www.keypedia.com/records/483/lupin-limited/cb2a61fc-450e-46a8-b38d-d73ceb8fec78)
- [483 - 2025-07-17](https://www.keypedia.com/records/483/lupin-limited/d00d48e1-5b54-4a56-ade6-d91c498b7c4a)
- [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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c