PBM Nutritionals, LLC – FDA EIR, Aug 15, 2019

An FDA inspection of PBM Nutritionals, LLC in Milton, VT, was conducted from August 12-15, 2019. This comprehensive review of the infant formula manufacturer was performed under the Infant Formula Compliance Program Guidance Manual 7321.006. The inspection revealed that the company operates as a private label and own brand manufacturer and packager of milk-based, dried, powdered infant and toddler formulas. The primary issue identified during the inspection, leading to a one-item FDA Form 483, Inspectional Observations, was the failure to maintain a cold storage area for an in-process infant formula at a temperature not exceeding a defined limit for a specified duration. The firm's electronic data for temperature control was not consistently reviewed or printed, and associated alarms were not challenged, indicating a gap in monitoring critical process parameters. While the company has existing deviation procedures for temperature excursions, this observation highlights a lapse in adherence to established temperature controls essential for product quality and safety. Corrective actions will be required to address this specific violation to ensure compliance with regulatory standards for infant formula manufacturing.