FDA EIR - Milupa GmbH - June 07, 2024

A surveillance inspection by the U.S. Food and Drug Administration (FDA) was conducted at Milupa GmbH in Fulda, Germany, from June 3 to June 7, 2024. The inspection, which was pre-announced, focused on the manufacturing of raw material components for infant formula and medical foods, such as KetoCal 3:1, intended for export to the United States. The primary violation identified, documented in an FDA-483, was that vitamin premixes used in the production of milk base powder were not tested for nutrient content to ensure compliance with raw material specifications. The company solely relied on suppliers' Certificates of Analysis for these values. This deficiency was a repeat observation from a previous FDA inspection in May 2023. In response, Ms. Peggy Tege, the Factory Director, was encouraged to submit a written corrective action plan to the FDA within 15 business days. The FDA classified this finding as "Voluntary Action Indicated," requiring the company to implement appropriate corrective measures.