PBM Nutritionals, LLC – FDA EIR, Sep 28, 2018

An FDA comprehensive inspection of PBM Nutritionals, LLC, a bulk powdered infant formula manufacturer in Covington, OH, occurred from September 25 to September 28, 2018. This inspection was conducted under the regulatory framework of Compliance Program 7321.006 for Infant Formula and Preventive Controls in Human Foods. The thorough review included manufacturing, sanitation, training, environmental monitoring, and complaint records. No significant violations were identified, and therefore, no FDA 483 Inspectional Observations form was issued.

However, one minor issue was raised: the company's sanitation records lacked the specific production aggregate number, also known as the Manufacturing Order (MO) number, for each infant formula processed. In response, PBM Nutritionals, LLC's Quality and Plant Managers promptly committed to rectifying this. They amended their sanitation monitoring forms before the inspection concluded to include a dedicated space for the MO number, ensuring this information would be recorded moving forward. Furthermore, the company, undergoing facility upgrades, committed to updating their HACCP/Food Safety Plan and performing Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) validation upon resuming manufacturing to ensure product quality and content uniformity.