# FDA 483 - Lupin Limited - April 04, 2022

Source: https://www.keypedia.com/records/483/lupin-limited/5acd6e49-aec0-480b-9c98-b660af087f3c

> FDA 483 for Lupin Limited on April 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2022-04-04
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Lupin Limited in Palghar, India, an API manufacturer, identified critical deficiencies in manufacturing processes, cleaning validation, in-process controls, and quality unit investigations. The firm failed to prevent contamination and cross-contamination of APIs, particularly with genotoxic impurities, due to the use of non-dedicated equipment and solvent recovery systems without adequate testing or cleaning validation. These systemic issues indicate a significant risk to the quality and safety of drug products intended for the US market.

## Related Documents

- [483 - 2019-09-20](https://www.keypedia.com/records/483/lupin-limited/6012146e-52c1-43f3-8900-ce7f0ca2cb6e)
- [483 - 2019-09-20](https://www.keypedia.com/records/483/lupin-limited/d6cb5c15-08e8-4f40-8520-87f69e1693f5)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/lupin-limited/c5d5c5f9-442a-476b-86e3-261a12e58f9b

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4