# FDA 483 - Lupin Ltd. - March 06, 2024

Source: https://www.keypedia.com/records/483/lupin-ltd/48e726de-aa36-4328-a07c-74dcddd776e0

> FDA 483 for Lupin Ltd. on March 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Ltd.
- Inspection Date: 2024-03-06
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Lupin Ltd. in Aurangabad, Maharashtra, India, a human drug manufacturer, was inspected by the FDA from March 6-15, 2024. The inspection revealed a failure to establish adequate written procedures for production and process controls. Specifically, the firm did not perform process validation for a new sanitization method used in a critical water system, which impacts drug products for the US market.

## Related Documents

- [EIR - 2017-04-17](https://www.keypedia.com/records/eir/lupin-ltd/7f110b33-b288-44d4-956e-a17d3f9dcb86)
- [483 - 2019-05-15](https://www.keypedia.com/records/483/lupin-ltd/20ca94d2-b604-4c19-84df-152b950f929a)
- [483 - 2025-09-05](https://www.keypedia.com/records/483/lupin-ltd/326bcd40-7462-477d-9bd8-e0098e42215f)

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/lupin-ltd/1c54bcbf-9d6e-4778-ba85-8d80e3806b2e

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