The U.S. Food and Drug Administration (FDA) has issued a warning letter to Yeshua Bendito, C.A., a Venezuelan seafood processing facility, citing violations of federal seafood safety regulations. The action follows a remote regulatory assessment conducted in June 2024 that revealed significant deficiencies in the company’s food safety protocols.
The FDA’s Foreign Remote Regulatory Assessment examined the facility located in San Francisco, Zulia, Venezuela, which processes cooked ready-to-eat crab meat products in reduced oxygen packaging. The assessment identified multiple violations of the Seafood Hazard Analysis and Critical Control Point regulation, which governs how seafood processors must identify and control food safety hazards.
According to the November 1, 2024 warning letter, only just recently published on the FDA website, the company’s products are considered adulterated under federal law because they were prepared under conditions that may render them injurious to health. The FDA determined that the facility failed to properly implement required safety plans and monitoring procedures.
The agency identified three major areas of non-compliance. First, the company’s hazard analysis failed to account for natural toxins and environmental chemicals that should be controlled when receiving crabs, as well as botulism toxin formation risks that require proper labeling of finished products. The FDA noted that frozen crab meat products lacked adequate safe handling instructions and temperature guidelines for consumers.
Second, the facility’s safety plan did not establish proper critical limits for cooling cooked crabs. The FDA requires that crabs be chilled to below 70 degrees Fahrenheit within one hour of cooking, then continuously cooled to 40 degrees or less within the following three hours. The current plan failed to account for cumulative cooling times across multiple processing steps.
Third, the monitoring procedures listed in the company’s safety plan were deemed inadequate for controlling bacterial growth and toxin formation, such as Clostridium botulinum, during refrigerated storage periods. Toxins from the pathogen Clostridium botulinum can result in botulism, a rare but dangerous illness that can lead to death. The FDA requires continuous monitoring of ambient cooler temperatures with daily data review to ensure safety standards are maintained.
The warning letter also referenced a May 2023 certificate of analysis that showed high levels of lead residues in the facility’s crab meat products, suggesting additional environmental contamination concerns.
Yeshua Bendito has fifteen working days to respond with documentation showing how they will correct these violations. The response must include revised hazard analysis and safety plans, along with five consecutive days of monitoring records demonstrating proper implementation.
If the company fails to respond adequately, the FDA may refuse admission of their imported seafood products into the United States. The agency can place products on detention without physical examination, an administrative procedure that would effectively block the company’s access to U.S. markets.
Food Poisoning News will continue to provide updates as they become available.
