The U.S. Food and Drug Administration (FDA) has sent a letter to Thai Union notifying it of committing violations of Hazard Analysis and Critical Control Point (HACCP) regulations at its tuna-processing factory in Samut Sakhon, Thailand.
The warning was issued on 20 April, 2022, following a remote assessment of Thai Union’s tuna processing facility in Samut Sakhon conducted by the FDA in January 2022.
In its letter, the FDA said it discovered serious violations of HACCP rules at the plant.
“Accordingly, your frozen, pre-cooked tuna loin products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” FDA said.
Under the seafood HACCP regulation, a company’s HACCP plan must include a critical limit. which is defined as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. However, the FDA said Thai Union’s HACCP plan for frozen precooked tuna loins was found to be inadequate to control the formation of scombrotoxin (histamine) at the precooking critical control point. The temperature distribution testing report and heat penetration testing report provided by Thai Union during the assessment was found as unsupportive of the critical limit required by HACCP regulations.
The U.S. agency also criticized the inadequacy of the facility’s monitoring frequency at some critical control points listed in Thai Union’s HACCP plan for frozen precooked tuna loins and the company’s failure to follow its monitoring procedure at its unrefrigerated processing critical control point for the required steps to control scombrotoxin (histamine) formation.
The FDA also deemed Thai Union’s corrective plan in relation to certain critical control points not to be effective. The FDA also urged Thai Union improve its operative processes and fix its critical limit deviations at the factory.
The FDA also recommended the company take measures to make sure the affected products are not issued for public consumption, such as chilling and holding the violated products until they are found to be in compliance with the regulations, destroying the products, or using them as non-food products.
Thai Union was requested to respond in writing to the FDA letter within 15 days after it received the warning. Failing to do so might result in the FDA taking punitive actions, including a possible refusal of Thai Union’s imported fish or fishery products into the U.S.
In a statement sent to SeafoodSource, Thai Union said it had responded to the FDA's requests and completed appropriate remedial actions.
"Thai Union values the critical role the FDA plays in the regulatory oversight of seafood imports and the health and safety of our customers. We want to always ensure the food safety of our products," the company said. "The letter detailed the ongoing communication between Thai Union staffs and the FDA in February and March. The letter also requested a series of updates to the Plant’s Hazard Analysis and Critical Control Point (HACCP) plan. The Thai Union Plant made all the recommended changes per the FDA’s updated HACCP regulations. These include updates to the processing and HACCP plan and most recently the monitoring frequency for the cooking temperature. Thai Union received a close-out letter from the FDA dated 8 September, 2022, saying 'Based on our evaluation, it appears you have addressed the deviations raised in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.' After the foreign remote regulatory assessment, the FDA allowed us to continue exporting our products to the US at all times."
Thai Union said its Samut Sakhon facility is now in full compliance with FDA's HACCP regulations.
"Thai Union has implemented all recommended changes according to the FDA’s updated HACCP regulations. These include updates to the processing and HACCP plan and most recently the monitoring frequency for the cooking temperature," a Thai Union spokesperson told SEafoodSource. "After the foreign remote regulatory assessment, the FDA allowed us to continue exporting our products to the U.S. at all times."
Photo courtesy of Thai Union
