Milupa GmbHJune 7, 2024

FDA 483 - Milupa GmbH - June 07, 2024

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An FDA inspection of Milupa GmbH in Fulda, Germany, revealed a repeat observation regarding the firm's infant formula manufacturing practices. The company failed to test each production aggregate of infant formula for nutrients in a nutrient premix, relying instead on supplier Certificates of Analysis. This deficiency indicates a potential quality control issue in ensuring product specifications are met.

Company: Milupa GmbH
Inspection Date: June 7, 2024
Product Type: Other
Office: Office of Biological Products Operations - Division I
People: Danny Tuntevski (Investigator)
Gale L. Glinecki (Investigator )

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ID · d402d244-a68c-4b2b-a599-34e8216d772e