FDA EIR - PBM Nutritionals, LLC - September 21, 2018

This FDA inspection of PBM Nutritionals, LLC, conducted from September 17-21, 2018, focused on infant formula manufacturing and consumer complaint follow-up, aligning with the Infant Formula Compliance Program Guidance Manual (CPGM) 7321.006. While the plant was undergoing routine preventative maintenance and equipment installation, a comprehensive review of operations, including sanitation, complaint handling, and product testing, was performed. The inspection specifically investigated "Infant Formula with Iron, Milk Based Powder" following a reported Salmonella case in an infant, though the firm's investigation found no manufacturing discrepancies. No objectionable conditions were observed during this inspection, and no Form FDA 483 (Inspectional Observations) was issued, indicating no formal violations. However, a key discussion centered on a customer's independent laboratory finding Cronobacter in a batch of "Infant Formula with Iron, Milk Based Powder, stage 2." This raised concerns regarding PBM Nutritionals' existing Cronobacter analysis methods, particularly its reliance on a background flora method and sample size, which was previously deemed effective under specific conditions. In response, the firm reviewed and reissued its Cronobacter sampling procedures on September 13, 2018. Furthermore, PBM Nutritionals committed to validating and implementing a new, enhanced Cronobacter sample analysis method by the end of October 2018, demonstrating a proactive approach to enhancing product safety and meeting regulatory expectations, including those related to 21 CFR 107.100 for nutrient specifications. Surveillance samples were collected for microbiological and nutrient analysis.