The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Trang Thuy Seafood Co. LTD
Tuy Hoa Phu Yen Province, Vietnam
A food firm in Vietnam is on notice from the U.S. Food and Drug Administration for violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a Nov. 3, 2023, warning letter, the FDA described an April 9-13, 2023, Foreign Remote Regulatory Assessment of Trang Thuy Seafood Co. LTD’s seafood processing facility in Fukuoka, Japan.
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.
Some of the significant violations are as follows:
1. The firm must conduct a hazard analysis to determine whether food safety hazards are reasonably likely to occur and have a HACCP plan that, at minimum, lists the critical control points. A “critical control point” is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied, and a food safety hazard can, as a result, be prevented, eliminated, or reduced to acceptable levels.” However, their HACCP plan for “Frozen Tuna Treated by CO,” dated April 25, 2023, does not list a critical control point to control scombrotoxin (histamine) formation during the transport of fresh tuna from the harvest vessel to the processing facility. For tuna delivered refrigerated or on ice from the harvest vessel, the FDA recommends a critical control point at receiving to ensure the fish were held at or below 40 degrees Fahrenheit (4.4 degrees Celsius), or completely surrounded by ice, throughout transit.
2. The firm must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point. However, their HACCP plan for “Frozen Tuna Treated by CO,” dated April 25, 2023, lists monitoring procedures that are inadequate to control scombrotoxin (histamine) formation.
a. The firm’s monitoring procedure of “(redacted by the FDA)” at a frequency of “(redacted by the FDA)” at the “(redacted by the FDA)” critical control point is not adequate. They should use a continuous temperature-recording device such as a recording thermometer to continuously monitor the temperature and perform a visual check of the recorded data at least once daily.
b. Their monitoring procedure of “(redacted by the FDA)” at a frequency of “(redacted by the FDA)” at the “(redacted by the FDA)” critical control point is not adequate. They should use a continuous temperature-recording device such as a recording thermometer to continuously monitor the temperature and perform a visual check of the recorded data at least once daily.
3. Because the firm chose to include a corrective action plan in their HACCP plan, they described corrective action as being appropriate. However, their corrective action plan for “Frozen Tuna Treated by CO,” dated April 25, 2023, does not ensure the cause of the deviation is corrected at their critical control points.
Additionally, the FDA offered the following comments:
- The critical limit is “Fish are removed from the viscera before chilled in ice, and it is chilled in ice at less than or equal to 4 degrees Celcius as soon as possible after harvest but does not exceed 12 hours after fish die. Fish were covered by ice above, under, (redacted by the FDA)” listed in their HACCP plan for “Frozen Tuna Treated by CO,” dated April 25, 2023, at the “(redacted by the FDA)” critical control point to control histamine formation is a parameter associated with onboard handling. However, the necessary limit does not state that they are collecting records documenting this information. The FDA acknowledges that their listed monitoring procedures indicate that they obtained this information from the harvest vessel and are checking the records received from the harvest vessel. To ensure that incoming fish are appropriately handled onboard the harvest vessel, the FDA recommends that their critical limit include that harvest records accompany all lots received.
- 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.
The full warning letter can be viewed here.
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