As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. 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.
Procesadora Vikingo C.A. — Venezuela
In a warning letter issued on March 6, 2024, the U.S. Food and Drug Administration (FDA) raised concerns about Procesadora Vikingo C.A., a Venezuelan seafood processor. The FDA’s Remote Regulatory Assessment, conducted from Sept. 11 to Sept. 15, 2023, identified multiple violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations for the company’s ready-to-eat (RTE) crabmeat products. Issues included inadequate corrective actions when cooking times deviated, failure to address allergen risks, and insufficient cooling and storage temperature monitoring. These violations raised concerns that the products could be harmful to consumers due to improper handling, including the lack of allergen control for blue crab and inadequate pathogen growth prevention.
The full warning letter can be viewed here.
Kyokuyo Global Seafoods Co. LTD. — Thailand
The FDA conducted an inspection of Kyokuyo Global Seafoods Co. LTD. from Jan. 19-22, 2024, and found several critical violations in the company’s Hazard Analysis and Critical Control Point (HACCP) plan for its seafood products, including mackerel and shrimp. The FDA noted that the plan did not adequately address the risks of histamine formation, Clostridium botulinum growth, and pathogen contamination, especially during the thawing process of frozen mackerel. The company’s failure to list critical control points for temperature monitoring during storage and transportation of seafood products raised concerns. The inspection also found that allergen labeling for seafood products was not properly controlled, potentially putting consumers at risk.
The full warning letter can be viewed here.
Grupo VPAS C.A. — Venezuela
During a Remote Regulatory Assessment of Grupo VPAS C.A. in Venezuela from Jan. 22-26, 2024, the FDA identified significant shortcomings in the company’s HACCP plan for its fresh-frozen Medregal fillets. The assessment highlighted that the company failed to include critical controls for temperature management during vessel offloading and transportation, which are necessary to prevent histamine formation and contamination by harmful bacteria such as Clostridium botulinum. The FDA also noted that the company’s HACCP plan did not list sufficient measures for testing histamine levels or controlling allergens, which are essential for consumer safety. The deficiencies in the plan could lead to unsafe food being distributed.
The full warning letter can be viewed here.
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