FDA WARNING_LETTER - American Distribution and Manufacturing Co., LLC - May 12, 2023

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of American Distribution and Manufacturing Co., LLC from April 13 to May 12, 2023, identifying significant violations of 21 CFR part 1, subpart L. The inspection focused on imported dry kibble cat food, dry kibble dog food, and a diatomaceous earth feed additive. The primary violations include the firm's failure to develop, maintain, and follow an FSVP, as mandated by section 805 of the FD&C Act and 21 CFR 1.502(a). Additionally, the company did not adequately conduct a written hazard analysis for imported foods, specifically failing to document the review and assessment of their foreign supplier’s hazard analysis, a requirement under 21 CFR 1.504(d). The company's response, citing unawareness of being the importer and plans to shift responsibility or hire a contractor, was addressed by FDA, clarifying the company's role as the importer per 21 CFR 1.500 and noting the absence of documented corrective actions. The FDA warns of potential refusal of admission (21 U.S.C. 381(a)(3)), detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. The company must respond within fifteen working days with detailed corrective actions and supporting documentation.