FDA WARNING_LETTER - Thai Union Group PLC - January 25, 2022

The FDA issued a Warning Letter to Thai Union Group PLC following a Foreign Remote Regulatory Assessment conducted on January 18-20 & 25, 2022, due to COVID-19 travel restrictions. The assessment identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen, pre-cooked tuna loin products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Critical Limits:** The HACCP plan for frozen pre-cooked tuna loins lists an inadequate critical limit at the Precooking critical control point (CCP 11) for controlling scombrotoxin (histamine) formation. Scientific studies provided (Temperature Distribution Testing Report and Heat Penetration Testing Report) do not support the listed critical limit and lack scientific validation for each cook tunnel and representative product forms. 2. **Inadequate Monitoring Frequency:** The HACCP plan's monitoring frequencies for unrefrigerated processing critical control points (CCP 10, CCP 12, CCP 13) are insufficient to control scombrotoxin and *Staphylococcus aureus* growth, as they lack a unit of time between measurements. 3. **Failure to Implement Monitoring Procedures:** The firm did not follow its listed monitoring procedure for CCP 10, with documented exposure times exceeding