FDA EIR - PBM Nutritionals, LLC - September 15, 2021

An FDA inspection of PBM Nutritionals, LLC, situated in Covington, OH, took place from September 13 to September 15, 2021. Investigator Matt D. Suedkamp led the inspection, which involved key company personnel including Senior Vice President of Global Operations Stephen Steffes, Associate Director of Operations Jeffery D. King, and Quality Assurance Manager Annette Jorgensen, among others. Management demonstrated full cooperation, and no refusals or issues with access were reported. The inspection focused on the company's compliance with regulations pertinent to the manufacturing of infant formula components, as evidenced by the review of documents related to infant formula nutrient information and changes in processing and formulation. It was noted that the facility produces an intermediate product intended for further processing, not a final marketable product. No product, environmental, or documentary samples were collected during the inspection. This specific report primarily outlines the administrative details of the visit; it does not explicitly state any identified violations or mandate any specific required actions following the inspection.