# FDA 483 - Lupin Limited - March 02, 2026

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/de1001f5-29f5-4dfa-ad9e-f3d0150f39d2

> FDA 483 for Lupin Limited on March 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2026-03-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Lupin Limited, an API manufacturer in Ankleshwar, India, revealed significant deficiencies in laboratory operations and production controls. The firm failed to thoroughly investigate numerous analytical incidents and did not follow established procedures for root cause analysis. Additionally, master production and control records lacked clearly defined time limits for processing steps, leading to observed variability.

## Related Documents

- [483 - 2022-08-16](https://www.globalkeysolutions.net/records/483/lupin-limited/2824070f-8472-4cbf-966a-43275ec641e5)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/9096bf53-ad6e-4b79-b306-969d59b29a91

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