# FDA 483 - Lupin Limited - August 16, 2022

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/2824070f-8472-4cbf-966a-43275ec641e5

> FDA 483 for Lupin Limited on August 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2022-08-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lupin Limited, an API/Intermediate manufacturer in Ankleshwar, Gujarat, India, was inspected by the FDA from August 16-19, 2022. The inspection revealed significant deficiencies in batch production records, indicating a lack of complete information regarding manufacturing calculations, checklists, ingredient dispensing, yield determination, and rationale for ingredient usage. These issues suggest potential problems with data integrity and process control.

## Related Documents

- [483 - 2026-03-02](https://www.globalkeysolutions.net/records/483/lupin-limited/de1001f5-29f5-4dfa-ad9e-f3d0150f39d2)

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/9096bf53-ad6e-4b79-b306-969d59b29a91

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