FDA EIR - PBM Nutritionals, LLC - August 24, 2017

An FDA inspection of PBM Nutritionals, LLC, an infant formula manufacturer in Georgia, VT, was conducted from August 21-24, 2017. This high-priority inspection, guided by the Infant Formula Compliance Program Guidance Manual 7321.006 and 21 CFR 117, focused on the company's production of cow’s milk-based powdered infant and toddler formulas. The inspection encompassed a facility walkthrough, evaluation of manufacturing equipment, warehouses, sanitation procedures, consumer complaint management, water quality, and stability testing. Crucially, no objectionable conditions were observed during this inspection, resulting in no FDA Form 483 Inspectional Observations being issued. This indicates the firm's compliance with regulatory standards at the time. The report confirmed that a previous observation from September 2016, related to inadequate hand washing facilities, had been successfully addressed with the installation of a new hand-sink. At the close-out meeting, FDA representatives discussed general regulatory updates, including new registration mandates, reinspection and recall user fees, and preventive control rules for human and animal food, but no specific violations or new required actions arose from this particular inspection.