# FDA 483 - Milupa GmbH - May 26, 2023

Source: https://www.keypedia.com/records/483/milupa-gmbh/ae62f52e-4dcc-4d4a-b2d7-ca996dda474b

> FDA 483 for Milupa GmbH on May 26, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Milupa GmbH
- Inspection Date: 2023-05-26
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: Milupa GmbH, an infant formula manufacturer in Fulda, Germany, received a Form 483 with five observations. The inspection revealed significant issues including the reprocessing of microbiologically contaminated infant formula base, inadequate monitoring of critical control points like metal detection, and insufficient testing of nutrient premixes. Additionally, the firm lacked proper temperature control studies for in-process storage and failed to calibrate critical processing instruments.

## Related Documents

- [483 - 2022-05-07](https://www.keypedia.com/records/483/milupa-gmbh/0c715c20-e237-4378-be5d-65b03f586e75)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/milupa-gmbh/d402d244-a68c-4b2b-a599-34e8216d772e)

## Related Officers

- [Megan E. Kerry](https://www.keypedia.com/people/megan-e-kerry/65b734af-9726-44a4-89f5-7f76d9b93a02)
- [investigator](https://www.keypedia.com/people/tressa-t-lewis/a6376b23-d22e-4116-9c23-88cecea2de10)
- [Elizabeth P. Mayer](https://www.keypedia.com/people/elizabeth-p-mayer/aa5dbd87-75dd-4717-b141-32a76056bd08)

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