Trang Thuy Seafood Co. LTD, located in Tuy Hoa Phu Yen Province, Vietnam, has received a warning letter from the U.S. Food and Drug Administration (FDA) for violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations.

Following a Foreign Remote Regulatory Assessment conducted by the FDA from April 9 to 13, 2023, at Trang Thuy Seafood Co. LTD’s seafood processing facility in Fukuoka, Japan, several violations were identified. The FDA inspection revealed non-compliance with U.S. federal regulations, prompting the issuance of a warning letter on November 3, 2023.

The FDA’s inspection revealed that the firm did not comply with U.S. federal regulations. The FDA discussed items of concern with the firm and provided them with a list of their violations.

Key violations outlined in the warning letter include:

1. Failure to conduct a hazard analysis and establish a HACCP plan with critical control points adequately. Specifically, the firm’s HACCP plan for “Frozen Tuna Treated by CO” did not address critical control points to control scombrotoxin (histamine) formation during the transportation of fresh tuna from the harvest vessel to the processing facility.
2. Inadequate monitoring procedures and frequencies for critical control points in the HACCP plan. Monitoring procedures listed in the plan were deemed insufficient to control scombrotoxin formation, requiring the use of continuous temperature-recording devices and daily visual checks.
3. Lack of an effective corrective action plan to address deviations at critical control points.

Additionally, the FDA provided recommendations and comments on the firm’s critical limits and monitoring procedures to ensure compliance with seafood regulations.The critical limit of “(redacted by the FDA)” listed in the firm’s HACCP plan for “Frozen Tuna Treated by CO,” dated April 25, 2023, at the “(redacted by the FDA)” critical control point does not identify where this temperature is obtained. The FDA acknowledges that their monitoring procedure states that the “(redacted by the FDA)” is monitored; however, the FDA recommends that their critical limit include that the internal fish temperatures at the time they are offloaded from the vessel are less than or equal to 4 degrees Celcius.

This warning serves as a notice to Trang Thuy Seafood Co. LTD to rectify the identified violations within a specified timeframe. Failure to address these issues may result in further regulatory action by the FDA.