# FDA 483 - Lupin Limited - September 18, 2021

Source: https://www.keypedia.com/records/483/lupin-limited/ecf78767-39d8-4119-8c17-5d01837ec150

> 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 Partnerships
- Summary: Lupin Limited, a drug product manufacturer in Verna, Goa, India, was cited with seven observations during an FDA inspection from September 6-18, 2021. The observations highlight significant deficiencies in quality control, including inadequate investigations into discrepancies, insufficient in-process material testing, and failure to validate component supplier test results. Additionally, issues were noted with annual product reviews, adherence to stability programs, and control over labeling materials.

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- [483 - 2019-02-08](https://www.keypedia.com/records/483/lupin-limited/2ce32ace-e257-49e8-b8f1-c34b45133d3e)

## 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-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3