Primal Pet Foods, Inc. – FDA Warning Letter, Oct 11, 2022

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