Milupa GmbHMay 7, 2022

FDA 483 - Milupa GmbH - May 07, 2022

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Record Details

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.

Company: Milupa GmbH
Inspection Date: May 7, 2022
Product Type: Other
Office: Office of Biological Products Operations - Division I
People: Jane Chen (Investigator)
Karen M. Labounty (Investigator)

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ID · 0c715c20-e237-4378-be5d-65b03f586e75