FDA 483 - American Distribution and Manufacturing Co, LLC - May 12, 2023

An FDA inspection of American Distribution and Manufacturing Co, LLC in Cottage Grove, MN, revealed significant deficiencies in its Foreign Supplier Verification Program (FSVP). The firm failed to establish and document a comprehensive FSVP, including lacking a written hazard analysis, proper supplier evaluations, and verification activities for imported pet foods and feed additives. These findings indicate a fundamental lack of compliance with foreign supplier oversight regulations.