# FDA 483 - Lupin Limited - November 23, 2022

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/9526924e-9742-43cf-b424-a50ea10b302e

> FDA 483 for Lupin Limited on November 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2022-11-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The inspection at Lupin Limited Unit I in Mandideep, India, revealed significant deficiencies in quality control, data integrity, and manufacturing practices. Observations included inadequate investigations into out-of-specification results, lack of proper computer system controls, failure to maintain complete records, and deficiencies in engineering practices and equipment calibration. These issues indicate a systemic breakdown in ensuring the quality and integrity of pharmaceutical products.

## Related Documents

- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/lupin-limited/7563e21c-3de3-472c-b7c2-896029346d00)
- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/lupin-limited/4a7b4f58-35ab-46da-bb80-3ddb7dbc5325)
- [483 - 2022-11-23](https://www.globalkeysolutions.net/records/483/lupin-limited/a8b2c8e0-ce26-40d8-ba9d-12baf6bad6fc)

## Related Officers

- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/122cdc90-be58-47a6-8127-004b3a6a04c3

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