# FDA 483 - Lupin Ltd. - September 05, 2025

Source: https://www.keypedia.com/records/483/lupin-ltd/326bcd40-7462-477d-9bd8-e0098e42215f

> FDA 483 for Lupin Ltd. on September 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Ltd.
- Inspection Date: 2025-09-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Lupin Ltd. in Aurangabad, Maharashtra, India, revealed two significant observations. The firm failed to properly qualify visual inspectors for finished drug capsule products, raising concerns about product quality assurance. Additionally, the company did not maintain adequate records for the cleaning of production equipment, specifically regarding cleaning chemical details.

## 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 - 2024-03-06](https://www.keypedia.com/records/483/lupin-ltd/48e726de-aa36-4328-a07c-74dcddd776e0)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

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

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