FDA 483 - PBM Nutritionals, LLC - June 17, 2025

PBM Nutritionals, LLC in Fairfax, VT, an infant formula manufacturer, was cited for three observations during an FDA inspection. The firm failed to maintain equipment surfaces to prevent contamination, did not collect representative samples for nutrient testing of finished infant formula, and failed to maintain proper cold storage temperatures. These issues indicate potential risks to product quality and safety.