FDA WARNING_LETTER - Arrow Reliance Inc - January 25, 2018

The FDA conducted an inspection of a raw pet food manufacturing facility in Tukwila, Washington, from December 2017 to January 2018, following customer complaints. The inspection and subsequent sample analysis revealed multiple raw pet food products were contaminated with *Salmonella*, *Listeria*, and/or Shiga toxin-producing *Escherichia coli O128*. These products are deemed adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, violating section 301(a) of the Act.

Specific contaminated products included various lots of Darwin's Natural Selections Turkey, Chicken, and Duck with Organic Vegetables Meals for Dogs, Darwin's ZooLogics Chicken and Duck Meals for Dogs, and Darwin's Natural Selections Duck Meals for Cats. Several of these contaminations led to Class I nationwide recalls. Previous recalls in 2016 and 2017 for *Listeria monocytogenes* and *Salmonella* were also noted. Whole Genome Sequencing (WGS) linked *Salmonella* from a deceased kitten to the firm's raw cat food and indicated potential facility contamination.

The FDA emphasized the need for a robust food safety system to prevent contamination, including proper cleaning, material testing, environmental monitoring, a kill step, and root cause investigations. Concerns were raised regarding the firm's use of bacteriophage to reduce pathogens, as their safety and efficacy