FDA WARNING_LETTER - OC Raw Dog LLC - May 26, 2021

The FDA inspected a raw dog food manufacturing facility in Corona, California, from April 16 to May 26, 2021, following a Class I recall of dog food due to Salmonella and Listeria monocytogenes. The FDA found the product adulterated under 21 U.S.C. § 342(a)(1) and identified violations of Hazard Analysis and Risk-Based Preventive Controls for animal food (21 CFR part 507, subpart C).

Key violations include: 1. **Inadequate Hazard Evaluation:** The facility's hazard analysis failed to evaluate environmental pathogens like Salmonella and Listeria monocytogenes, despite raw dog food being exposed to the environment before packaging without subsequent pathogen-minimizing treatment. Observations revealed sanitation practices, such as high-pressure rinsing and fan use, could aerosolize and disperse contaminants. The firm's proposed corrective action of using (b)(4) lacked validation data specific to their process. 2. **Lack of Preventive Control Validation:** The firm did not validate its process preventive control, the application of (b)(4) at the chipping step, to control Salmonella, L. mono, and E. coli. The provided validation study was deemed inadequate as it did not align with the firm's specific products (frozen lamb, poultry, fish in addition to beef) or processing methods.

Environmental sampling by FDA confirmed the presence of Listeria innocua and Lister