FDA WARNING_LETTER - Agustson A/S - March 08, 2024

On August 13, 2024, the FDA issued a Warning Letter to Agustson A/S following a March 7-8, 2024, inspection of their seafood processing facility in Denmark. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen, reduced-oxygen packed hot smoked trout fillets adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Despite multiple responses from Agustson A/S, the FDA found continued serious concerns with their HACCP program. Key violations include: 1. Failure to identify agriculture drugs and *Staphylococcus aureus* growth and toxin formation as food safety hazards in their HACCP plan for "Hot Smoked trout Fillets (farm-raised), Reduced-Oxygen Packed, Frozen." 2. Failure to list a critical control point to control pathogenic bacteria growth and toxin formation during refrigerated storage. 3. Inadequate critical limits for pathogenic bacteria growth and survival at the "CCP 5: (b)(4)" critical control point, specifically regarding *Listeria monocytogenes* reduction and internal temperature for (b)(4) operations. 4. Failure to list monitoring procedures for minimum brining time to control *Clostridium botulinum* growth and toxin formation.

The FDA also noted a separate Warning Letter issued on