FDA 483 - PBM Nutritionals, LLC - July 21, 2023

PEM Nutritionals, LLC, an infant formula manufacturer in Covington, OH, was cited for significant quality control failures during an FDA inspection. Observations included inadequate process controls leading to Cronobacter contamination in both environmental samples and finished product, as well as the use of expired ingredients and reworked expired finished product. Additionally, the firm failed to adequately clean and sanitize equipment between production campaigns, posing a risk of contamination.