Milupa GmbH – FDA EIR, May 7, 2022

A Food and Drug Administration (FDA) inspection of Milupa GmbH, a German manufacturer of medical foods and exempt infant formulas, was conducted from May 3 to May 7, 2022. This pre-announced comprehensive inspection, aligning with FDA's Infant Formula Program, Medical Foods Program, and Preventive Controls and Sanitary Human Food Operations Compliance Programs, identified several deficiencies. The inspection revealed issues that led to the issuance of an FDA Form 483. Key violations included inadequate plant sanitation and maintenance, evidenced by duct-taped fixtures and flaking paint in high-care areas. Deficiencies were also noted in preventive controls records, specifically regarding the accurate recording of Critical Control Point (CCP) monitoring data for bulk base powder, where actual values were not documented correctly. The firm was cited for failing to conduct operations under conditions designed to minimize microbial growth, with further discussions encompassing direct heating, employee practices, validation, and general sanitation. Additionally, a label review of the KetoCal 4:1 product suggested ingredients might not be listed in order of predominance by weight. Milupa GmbH management committed to implementing necessary corrections and providing a written response to the FDA 483 within 15 business days. The FDA classified the inspection as "Voluntary Action Indicated" (VAI), recommending routine follow-up to ensure compliance.