Arrow Reliance Inc. – FDA Warning Letter, Sep 30, 2022

The FDA issued a Warning Letter to Darwin’s Natural Pet Products after consumer complaints and subsequent inspections revealed significant violations. Initial FDA analysis of Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Turkey Recipe for Cats, prompted by reports of kitten illness, confirmed *Salmonella* contamination. A follow-up inspection at their Tukwila, Washington facility from August to September 2022 found an additional lot of chicken recipe also contaminated with *Salmonella*. These products are deemed adulterated under 21 U.S.C. § 342(a)(1) because *Salmonella* may render them injurious to health for both animals and humans. The firm's response to the FDA 483 was inadequate, failing to detail corrective actions or recurrence prevention for *Salmonella*. Additionally, the company was cited for using peroxyacetic acid (PAA) as a pathogen mitigation step at concentrations up to (b)(4) ppm, which is an unapproved and unsafe animal food additive, causing further adulteration under 21 U.S.C. § 348(a)(2). The FDA is unaware of data demonstrating PAA's GRAS status for animal food, and the firm's usage exceeds permitted human food levels. Finally, the facility failed to register with FDA as required by 21 U.S.C. § 350d and 21 CFR Part 1, Subpart H, as it does not qualify as a retail food establishment. The FDA requires a written response within 15 working days detailing corrective actions and prevention plans, warning of potential legal action including seizure and injunction, and noting future inspections will assess compliance with 21 CFR Part 507 (CGMP and Preventive Controls for Food for Animals).