FDA EIR - PBM Nutritionals, LLC - September 28, 2020

An FDA inspection of PBM Nutritionals, LLC, an infant and toddler formula manufacturer located in Milton, VT, was conducted from September 21 to September 28, 2020. This comprehensive inspection was performed under the Infant Formula Compliance Guidance Manual (CPGM) 7321.006 and other relevant guidance, focusing on the firm's operations as a private label and own-brand manufacturer of cow's milk-based powdered formulas. Unlike the previous inspection in August 2019, which resulted in a single observation regarding cold storage temperatures for in-process infant formula, the current inspection found no objectionable conditions. Consequently, no FDA Form 483, Inspectional Observations, was issued. The inspection included a walkthrough of the manufacturing facility, review of consumer complaints (including serious adverse events), water quality, finished product testing, environmental monitoring, manufacturing design, packaging, and new formulations. The firm had also submitted several major packaging and new-to-market infant formula submissions to CFSAN since the last inspection, all of which were cleared. Two consumer complaints were reviewed, with investigations concluding no anomalies linked to the firm's products. Routine samples were collected for microbiological and nutrient analysis. Management was informed that no new observations were made, and follow-up on the 2019 observation would be handled separately by CFSAN or CB if further information was needed. This inspection indicated the firm's operations were in compliance with regulatory standards.