FDA EIR - PBM Nutritionals, LLC - August 23, 2019

An FDA inspection of PBM Nutritionals, LLC., a contract manufacturer of bulk powdered infant formula located in Covington, Ohio, was conducted from August 22-23, 2019. This abbreviated inspection was carried out under the regulatory framework of the Infant Formula Program (Compliance Program Guidance Manual 7321.006 Infant Formula – Import and Domestic) and the Medical Foods Program (7321.002), affirming the firm's subjection to the FD&C Act. During the inspection, the facility was undergoing renovations and system updates, meaning manufacturing operations were temporarily suspended. Consequently, the inspection primarily involved a comprehensive review of documents and interviews with management. Key documents examined included batch records, processing water testing, calibration records, sanitation records, the recall plan (noting a January 2019 recall due to mechanical issues), complaint logs, and pest control records. Significantly, the inspection revealed no objectionable conditions or deficiencies. A previous inspection's sole discussion item regarding sanitation record completeness had been corrected. Management was cooperative throughout the process, and no FDA Form 483 (Inspectional Observations) was issued. The inspector recommended a "No Action Indicated" (NAI) classification, indicating that no regulatory or administrative actions are necessary. No specific required actions were identified for the company as a result of this inspection.