# FDA 483 - Lupin Limited - September 18, 2021

Source: https://www.keypedia.com/records/483/lupin-limited/43a586e1-9912-4c60-bdbe-09e846247eb3

> FDA 483 for Lupin Limited on September 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2021-09-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lupin Limited, a drug product manufacturer in Verna, Goa, India, received a Form 483 with seven observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into discrepancies, insufficient in-process material testing, and a failure to validate component supplier test results. Additionally, issues were noted with annual product reviews not including returned products, non-adherence to stability programs, and uncontrolled access to labeling materials.

## Related Documents

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/lupin-limited/218ee27f-639e-4fc4-995c-345bc58c3548

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