# FDA 483 - Lupin Manufacturing Solutions Limited - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/lupin-manufacturing-solutions-limited/23c400c0-6de8-4bfd-a3f8-971f0c77cf7b

> FDA 483 for Lupin Manufacturing Solutions Limited on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Manufacturing Solutions Limited
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: Lupin Limited, an API manufacturer in Visakhapatnam, India, was cited with five observations during an FDA inspection in January 2020. The inspection revealed significant deficiencies in process validation, discrepancy investigations, control of reference standards, raw material sampling, and master batch record controls. These issues indicate a lack of robust quality systems for API manufacturing.

## Related Documents

- [483 - 2020-01-17](https://www.globalkeysolutions.net/records/483/lupin-manufacturing-solutions-limited/a9b30d56-7ebd-41de-8ce5-2a10a5805359)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/lupin-manufacturing-solutions-limited/aa17e052-450b-4bc5-b441-515d96f18b2d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb