American Distribution and Manufacturing Co., LLC

Warning LetterOpen

Mr. Jon Duclos Owner American Distribution and Manufacturing Co., LLC 7900 97th St S Cottage Grove , MN 55016-4343 United StatesFEI 3003974891Issued Oct 12, 2023Division of Northern Border Imports

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Violations4

Issue DateOct 12, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: American Distribution and Manufacturing Co., LLC
Location: Mr. Jon Duclos Owner American Distribution and Manufacturing Co., LLC 7900 97th St S Cottage Grove , MN 55016-4343 United States
FEI Number: 3003974891
Country: United States
Issue Date: October 12, 2023
Issuing Office: Division of Northern Border Imports
Product Type: Other
Status: Open

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.

American Distribution and Manufacturing Co., LLC FDA Warning Letter, October 12, 2023