FDA WARNING_LETTER - Raw Advantage Processing LLC - August 30, 2019

The FDA inspected a pet food manufacturing facility at 12264 Silver Falls Highway SE, Aumsville, Oregon, from August 26-30, 2019, and documented significant violations of 21 CFR Part 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. Failure to comply with these provisions is prohibited by section 301(uu) of the FD&C Act, and adulterated food is prohibited under section 301(a).

Key violations include: 1. **Failure to identify and evaluate known or reasonably foreseeable hazards (21 CFR 507.33(a)(1))**: The firm's hazard analyses for raw ground pet food did not identify or evaluate *Listeria monocytogenes* for products not undergoing (b)(4) treatment, nor did it evaluate microbiological hazards like *E. coli*, *Listeria*, and *Campylobacter* from raw goat milk in products that undergo (b)(4). 2. **Failure to evaluate environmental pathogens (21 CFR 507.33(c)(2))**: The hazard evaluation did not include environmental pathogens despite raw meat being exposed to the environment prior to packaging and the packaged food not receiving a lethal treatment. Environmental samples collected during the inspection yielded *Listeria monocytogenes* in six locations, including the grinder/mixer room.