FDA EIR - PBM Nutritionals, LLC - October 10, 2019

An FDA inspection of PBM Nutritionals, LLC's Covington, Ohio facility occurred on October 10, 2019. This compliance-directed, limited-scope inspection, conducted under the "Infant Formula Survey" regulatory framework, was a response to a Class 1 recall in Canada concerning their President's Choice Lower Iron milk-based powdered infant formula. While the specific lot linked to the recall tested negative for pathogens, the inspection revealed subsequent positive *Cronobacter* findings in two other infant formula lots. One bulk production lot, associated with a processing