# FDA 483 - PBM Nutritionals, LLC - July 21, 2023

Source: https://www.keypedia.com/records/483/pbm-nutritionals-llc/87f95c05-77b6-4dea-a8fd-f9d006f4606e

> FDA 483 for PBM Nutritionals, LLC on July 21, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PBM Nutritionals, LLC
- Inspection Date: 2023-07-21
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: PEM Nutritionals, LLC, an infant formula manufacturer in Covington, OH, was cited for significant quality control failures during an FDA inspection. Observations included inadequate process controls leading to Cronobacter contamination in both environmental samples and finished product, as well as the use of expired ingredients and reworked expired finished product. Additionally, the firm failed to adequately clean and sanitize equipment between production campaigns, posing a risk of contamination.

## 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 - 2025-06-12](https://www.keypedia.com/records/483/pbm-nutritionals-llc/4b6526c6-d587-4f81-bd42-ad68688fac09)
- [483 - 2025-06-12](https://www.keypedia.com/records/483/pbm-nutritionals-llc/3c47be5f-9701-4e57-b255-dfcf5a69ab67)

## Related Officers

- [Said H. Muse](https://www.keypedia.com/people/said-h-muse/47b59180-654a-42d2-a7a6-4152508173ef)
- [Ashley R Keiser](https://www.keypedia.com/people/ashley-r-keiser/4d871237-0823-4bea-ad3b-38d7f6bc47d5)
- [Kelsey L. Vansickle](https://www.keypedia.com/people/kelsey-l-vansickle/9bb93edc-9bb1-4a7a-a883-6e65d1cd7996)
- [Elizabeth P. Mayer](https://www.keypedia.com/people/elizabeth-p-mayer/aa5dbd87-75dd-4717-b141-32a76056bd08)
- [investigator](https://www.keypedia.com/people/jennifer-m-heitz/b520050f-390e-45ab-b528-ad32f5c86883)

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