American Distribution and Manufacturing Co., LLC Warning Letter Details

Summary

American Distribution and Manufacturing Co., LLC failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for imported pet food products (dry kibble cat food and dog food) and a diatomaceous earth feed additive, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. During an inspection conducted from April to May 2023, the FDA identified significant compliance failures in the company's risk-based verification activities intended to ensure imported animal food met applicable U.S. food safety standards. The company's written response to the FDA's observations dated June 13, 2023, did not adequately address the violations.