# FDA 483 - Lupin Limited - July 17, 2025

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/6f335fb2-3d0d-4d12-baba-38bdf30583a1

> FDA 483 for Lupin Limited on July 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2025-07-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Lupin Limited, a human drug manufacturer in Pithampur, India, revealed significant deficiencies in quality control. The firm failed to adequately test components, thoroughly investigate customer complaints regarding product defects, and establish proper written procedures for in-process controls and electronic data review. These issues indicate a lack of robust quality management systems.

## Related Documents

- [483 - 2017-06-16](https://www.globalkeysolutions.net/records/483/lupin-limited/d4595e7b-72b0-4e7a-afda-5ba3e7b0084b)
- [483 - 2018-10-18](https://www.globalkeysolutions.net/records/483/lupin-limited/93074ac1-299c-4b90-9076-b1aac2c894e1)
- [483 - 2018-10-18](https://www.globalkeysolutions.net/records/483/lupin-limited/b652c954-f2ff-4c65-8d9f-10f5f29884ed)
- [483 - 2025-07-17](https://www.globalkeysolutions.net/records/483/lupin-limited/f4979117-c0b8-4ccb-bdf3-d5cab68eacb0)

## Related Officers

- [RafaeQ A Habash](https://www.globalkeysolutions.net/people/rafaeq-a-habash/c594bd13-9866-412d-984d-64a398aaf6b6)
- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/d2616722-956d-4898-88a7-c22b7bd321a2

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8