# FDA 483 - Lupin Limited - March 29, 2023

Source: https://www.keypedia.com/records/483/lupin-limited/221b0dd1-0d74-4087-b84d-d18d441c876e

> 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: Office of Biological Products Operations - Division I
- Summary: Lupin Limited in Pithampur, India, received a Form 483 with 10 observations following an inspection from March 21-29, 2023. The observations highlight significant deficiencies in quality control, including inadequate investigations of OOS results and complaints, poor data integrity controls, and insufficient personnel training. The firm also failed to maintain proper environmental controls and sterility assurance for drug products.

## Related Documents

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- [483 - 2023-03-29](https://www.keypedia.com/records/483/lupin-limited/cb2a61fc-450e-46a8-b38d-d73ceb8fec78)
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- [483 - 2023-03-29](https://www.keypedia.com/records/483/lupin-limited/f06831df-7020-4ea9-8e5d-b47ca946e828)

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1