FDA issued a Warning Letter to Arrow Reliance of Tukwila, WA, a manufacturer of cat food including Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwin’s Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats.
The inspection was " in response to a consumer complaint received about your products causing illness in the customer’s kittens. FDA laboratory analysis revealed these products to be contaminated with Salmonella. Further, during a follow-up inspection of [the] manufacturing facility, located at 350 Treck Drive, Tukwila, Washington, from August 23, 2022, through September 30, 2022, FDA collected an additional sample of your Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats. FDA laboratory analysis revealed this product was also contaminated with Salmonella."
The company tried to argue that Salmonella is not an issue in animal feed, but FDA responded, "The association between human illness or outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established.6 Association with pet illness has also been shown.7 Thus, FDA considers a pet food to be adulterated if it is contaminated with Salmonella, regardless of the quantity or Salmonella serotype; however, Salmonella typhimurium is one of the most common serotypes that causes human infection."
The company was also spraying product with PAA (peroxyacetic acid) as a control, but this is not an approved application for this sanitizer. "FDA Investigators noted you continue to use PAA as a pathogen mitigation step and you have increased your PAA concentration from (b)(4) ppm to (b)(4) ppm on the advice of your PAA supplier and a third-party laboratory. There is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Part 582 or 584 as a substance that is GRAS for the intended use. Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food."
The company was also not registered with FDA. They stated that they ship direct to consumers thorogh the use of third party warehouses...of course, this is distribution and not retail sales. The "Director of Quality informed FDA’s Investigators that the majority of your product (approximately (b)(4) percent) is shipped directly to consumers from third-party warehouses rather than from your facility. Thus, your manufacturing facility is not a retail food establishment as defined in 21 CFR 1.227."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/arrow-reliance-inc-644947-02162023
Arrow Reliance Inc.MARCS-CMS 644947 — FEBRUARY 16, 2023