FDA 483 - Milupa GmbH - May 26, 2023

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.