# FDA 483 - PBM Nutritionals, LLC - June 12, 2025

Source: https://www.keypedia.com/records/483/pbm-nutritionals-llc/3c47be5f-9701-4e57-b255-dfcf5a69ab67

> FDA 483 for PBM Nutritionals, LLC on June 12, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PBM Nutritionals, LLC
- Inspection Date: 2025-06-12
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: PBM Nutritionals, LLC in Covington, OH, was cited for significant deficiencies in its environmental monitoring program during an inspection of its infant formula manufacturing. The firm failed to establish adequate process controls to prevent infant formula from becoming adulterated due to microorganisms, specifically Cronobacter sakazakii. This observation regarding process controls was a repeat finding from a previous inspection.

## Related Documents

- [EIR - 2018-09-28](https://www.keypedia.com/records/eir/pbm-nutritionals-llc/7523cf95-bd72-4e51-8852-2d8372060ef0)
- [EIR - 2019-08-23](https://www.keypedia.com/records/eir/pbm-nutritionals-llc/371ffb59-a6db-4aef-8040-47583f90b73a)
- [EIR - 2021-09-15](https://www.keypedia.com/records/eir/pbm-nutritionals-llc/d2846b2d-6b89-4ca1-8e42-8b3fc1ed319c)
- [483 - 2023-07-21](https://www.keypedia.com/records/483/pbm-nutritionals-llc/87f95c05-77b6-4dea-a8fd-f9d006f4606e)
- [483 - 2025-06-12](https://www.keypedia.com/records/483/pbm-nutritionals-llc/4b6526c6-d587-4f81-bd42-ad68688fac09)

## Related Officers

- [Emily E. Krumel](https://www.keypedia.com/people/emily-e-krumel/21f9f34a-0535-4e31-84cb-f3331d2f8cdd)
- [Herman S. Clincy](https://www.keypedia.com/people/herman-s-clincy/31f24de6-4b88-4698-87e1-9dc00f59f595)
- [Isaiah D Davis](https://www.keypedia.com/people/isaiah-d-davis/352dc581-9150-410a-bb77-c8258cb13ef6)
- [Josiah D. Davis](https://www.keypedia.com/people/josiah-d-davis/43445c8f-caeb-4f40-ae45-424328d540f2)
- [Carlos H. Ruiz Nunez](https://www.keypedia.com/people/carlos-h-ruiz-nunez/8a464314-c72a-4194-9018-8698457b2fb3)

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