# FDA 483 - Milupa GmbH - May 07, 2022

Source: https://www.keypedia.com/records/483/milupa-gmbh/0c715c20-e237-4378-be5d-65b03f586e75

> FDA 483 for Milupa GmbH on May 07, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Milupa GmbH
- Inspection Date: 2022-05-07
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Milupa GmbH in Fulda, Germany, revealed a significant issue with microbiological control during the production of a specific product. The firm failed to establish adequate process controls, specifically critical limits for temperature and hold time, to prevent the potential for microbial growth. This indicates a serious concern regarding product safety and quality.

## Related Documents

- [483 - 2023-05-26](https://www.keypedia.com/records/483/milupa-gmbh/ae62f52e-4dcc-4d4a-b2d7-ca996dda474b)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/milupa-gmbh/d402d244-a68c-4b2b-a599-34e8216d772e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jane-chen/4f0b3c6c-44e9-4db4-a140-4c1d5761ee55)
- [Investigator](https://www.keypedia.com/people/karen-m-labounty/66d6e00f-20e1-4c6b-a997-443db6cbfeee)

Company: https://www.keypedia.com/companies/milupa-gmbh/a406d6b0-df46-4822-8cfb-732831ba1f7c

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