Milupa GmbH – FDA EIR, May 26, 2023

An FDA inspection of Milupa GmbH in Fulda, Germany, was conducted from May 22 to May 26, 2023. This pre-announced surveillance inspection focused on the manufacturing of powdered medical foods and base powders used in infant formulas and medical foods, particularly bulk milk-protein base powders for the U.S. market. The inspection adhered to relevant FDA compliance programs for infant formula and medical foods. The inspection resulted in an FDA Form 483, Inspectional Observations, detailing several significant issues. Main violations included the firm's failure to operate under conditions that minimize food contamination, specifically by reintroducing adulterated base powders into the product stream. Other observations noted inadequate monitoring of critical production control points, improper temperature maintenance for in-process infant formula storage, insufficient testing of infant formula production batches for nutrient compliance, and poor maintenance of processing instruments. Milupa GmbH was instructed to provide a written response to the FDA 483 observations within 15 days, a commitment the firm acknowledged. The overall inspection was classified as Voluntary Action Indicated (VAI) for certain infant formula raw material processes, with a re-inspection planned for the future.