FDA 483 - PBM Nutritionals, LLC - June 12, 2025

An FDA inspection of PBM Nutritionals, LLC, conducted from June 3 to June 12, 2025, identified significant deficiencies in the firm's process controls for infant formula manufacturing. The primary violation observed was the company's failure to establish a robust system to prevent microbial adulteration, specifically regarding Cronobacter sakazakii, in its infant formula products and processing environment. Investigators noted critical shortcomings in the environmental monitoring program. The company did not adequately investigate positive findings of Cronobacter sakazakii in composite swabs, failing to identify specific contamination sources. Furthermore, PBM Nutritionals, LLC, neglected to consider all potential contamination routes during root cause analyses, even for areas with a documented history of microbial positives. This critical observation regarding process controls is a repeat finding from a prior FDA inspection on July 21, 2023. Under the Federal Food, Drug, and Cosmetic Act, these observations indicate practices that could lead to adulterated products. PBM Nutritionals, LLC is expected to address these deficiencies by implementing comprehensive corrective actions to ensure infant formula safety. The company is encouraged to submit information regarding objections or planned corrective actions to the FDA.