# FDA WARNING_LETTER - Primal Pet Foods, Inc. - October 11, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/primal-pet-foods-inc/9708e027-f998-40c5-b2f1-9ed6d4d06a6f

> FDA WARNING_LETTER for Primal Pet Foods, Inc. on October 11, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Primal Pet Foods, Inc.
- Inspection Date: 2022-10-11
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: On February 21, 2023, the FDA issued a Warning Letter to Primal Pet Foods, Inc. following an inspection from July 14 to October 11, 2022. The inspection was prompted by a Class I recall on July 6, 2022, of Raw Frozen Primal Patties for Dogs Beef Formula due to *Listeria monocytogenes* detected in an FDA surveillance sample.

The inspection revealed significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation (21 CFR Part 507), rendering products adulterated.

Key violations include:
1.  **Failure to identify and implement effective preventive controls for pathogens (21 CFR 507.34(a)(1)):** Despite identifying pathogens (*Salmonella spp.*, *Listeria monocytogenes*, *E. coli O157:H7*) as hazards, 49 products tested positive for *Listeria monocytogenes* or *Salmonella spp.* between August 2021 and August 2022, demonstrating ineffective controls. The firm's proposed corrective actions, including reclassifying supplier approval and testing, and adding a sanitation control, lacked sufficient supporting documentation for evaluation.
2.  **Failure to sufficiently assess hazard probability (21 CFR 507.33(c)(1

## Related Officers

- [Darla R. Bracy](https://www.globalkeysolutions.net/people/darla-r-bracy/ff507c75-ede3-4915-9aea-d8971842d891)
- [Matthew Koss](https://www.globalkeysolutions.net/people/matthew-koss/ae886f30-9fee-495e-90ad-03385048ac25)

Company: https://www.globalkeysolutions.net/companies/primal-pet-foods-inc/43bb0828-10ca-410c-b90b-934aa8e32285

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b