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

Source: https://www.keypedia.com/records/eir/pbm-nutritionals-llc/371ffb59-a6db-4aef-8040-47583f90b73a

> FDA EIR for PBM Nutritionals, LLC on August 23, 2019. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: PBM Nutritionals, LLC
- Inspection Date: 2019-08-23
- Product Type: Other
- Office Name: Cincinnati District Office
- Summary: 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.

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## Related Officers

- [company_representative](https://www.keypedia.com/people/jeffery-d-king/4b8a168a-a12a-4f7b-997b-197ff9342b11)
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- [company_representative](https://www.keypedia.com/people/amjad-khanfar/c843a67d-9050-4d26-81ee-d5ead327a965)

Company: https://www.keypedia.com/companies/pbm-nutritionals-llc/9466f41a-04b8-4ca4-8489-b1fa72d846ed

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22