FDA 483 - Cooke Aquaculture USA Inc - February 23, 2024

An FDA inspection of Cooks Aquaculture USA Inc. in Machiasport, ME, revealed a significant compliance issue regarding their Foreign Supplier Verification Program (FSVP). The firm failed to develop an FSVP for imported fish feed, a critical requirement for ensuring the safety of imported food products. This indicates a fundamental lapse in their regulatory obligations.