FDA 483 - PBM Nutritionals, LLC - August 15, 2019

An FDA inspection of PBM Nutritionals, LLC, an infant formula manufacturer in Milton, VT, identified a significant concern regarding the cold storage of in-process infant formula. The firm failed to maintain appropriate temperatures and lacked sufficient data to support its holding procedures, raising potential risks of microbial growth. This indicates a critical lapse in quality control for a sensitive product.