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.

Yeshua Bendito, C.A.
San Francisco, Zulia, Venezuela

The U.S. Food and Drug Administration has issued a warning letter to Yeshua Bendito, C.A., a seafood processing facility located in San Francisco, Zulia, Venezuela, for significant violations of the U.S. seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The violations were identified during a Foreign Remote Regulatory Assessment (FRRA) conducted from June 10 to 14, 2024, at the company’s facility, which processes cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP).

The FDA determined that Yeshua Bendito’s crab meat products are adulterated under the Federal Food, Drug, and Cosmetic Act because they were prepared, packed, or held under conditions that could render them injurious to health. The warning letter, issued on Nov. 1, 2024, and posted in recent days, outlines serious deficiencies in the company’s HACCP plan that could lead to hazards such as Clostridium botulinum toxin formation, natural toxins, and environmental chemical contamination.

Critical violations

During the FRRA, the FDA identified several key violations in Yeshua Bendito’s HACCP plan:

1. Inadequate hazard analysis: The company’s hazard analysis failed to address natural toxins and environmental chemicals at the receiving crabs critical control point (CCP). Additionally, it did not account for Clostridium botulinum toxin formation at the finished product labeling CCP. Specifically, the labels for 12 oz frozen ROP crab meat only stated “Keep Refrigerated” without specifying a temperature range (32 degree F to 38 degrees F) or including required instructions such as “Keep frozen until used, thaw under refrigeration immediately before use.” This omission increases the risk of improper storage and potential botulism poisoning.
2. Missing critical limits for cooling: The HACCP plan did not include critical limits for the cooling of cooked crabs at the Crab Refrigeration CCP. The FDA noted that the cumulative time for chilling crabs to below 21.1 degrees C (70 degrees F) should be less than 1 hour, with continuous chilling to 4.4 degrees C (40 degrees F) or below within the subsequent 3 hours. These limits were not specified, and internal temperatures were not monitored hourly as required.
3. Inadequate monitoring procedures: The HACCP plan listed monitoring procedures at the Crab Refrigeration Cooked CCP and Storage of Finished Product CCP that were insufficient to control pathogenic bacteria growth and toxin formation. The FDA recommends using continuous data loggers with daily reviews to monitor ambient cooler temperatures during refrigerated holding periods.

Additional concerns
The FDA also highlighted a certificate of analysis from May 28, 2023, showing high levels of lead residues in crab meat. The agency suggested that Yeshua Bendito identify environmental chemicals as a food safety hazard in its HACCP plan, as such residues could render the seafood adulterated.

FDA action and next steps
At the conclusion of the FRRA, the FDA issued an Observations letter to Yeshua Bendito, but the company has not responded to the identified issues. The FDA has requested a written response within 15 working days, detailing corrective actions, including a revised HACCP plan, five consecutive days of monitoring records, and other documentation to demonstrate compliance. Failure to address these violations could lead to further regulatory action, including refusal of the company’s products for entry into the United States and placement on import alert #16-120, which allows detention without physical examination.

The full warning letter can be found here.

Eden F&C Co. Ltd
Boeun-gun, Chungcheongbuk-do, South Korea

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Eden F&C Co. Ltd, a seafood processing facility located at 6381 Nambu-Ro, Naebung-Myeon, Boeun-gun, Chungcheongbuk-do, South Korea, for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The violations were identified during an inspection on April 26, 2024, at the facility, which processes ready-to-eat (RTE) seafood-containing corn dog products, specifically frozen fish sausage corn dogs in vacuum packaging.

The FDA determined that Eden F&C’s fish sausage corn dog products are adulterated under the Federal Food, Drug, and Cosmetic Act because they were prepared, packed, or held under conditions that could render them injurious to health. The warning letter, issued on Nov. 6, 2024, and posted in decent days, highlights deficiencies in the company’s HACCP plan that increase the risk of non-proteolytic Clostridium botulinum growth and toxin formation, a serious food safety hazard that can cause botulism.

Critical violations
During the inspection, the FDA identified the following significant violations in Eden F&C’s HACCP plan:

1. Missing critical control point for receiving: The company’s HACCP plan for frozen fish sausage corn dogs did not include a critical control point (CCP) at the receiving step for cooked vacuum-packed fish sausages delivered in refrigerated trucks from their supplier. This step is essential to control the hazard of non-proteolytic Clostridium botulinum growth and toxin formation. The FDA noted that the plan’s receiving criteria were inadequate, as it did not ensure the refrigeration unit’s ambient temperature was maintained below 3.3 degrees C (38 degrees F) with continuous monitoring throughout transit.
2. Inadequate critical limits for storage: The HACCP plan listed a critical limit at the storage process CCP that was not sufficient to control non-proteolytic Clostridium botulinum growth and toxin formation in vacuum-packed products. The FDA recommends a critical limit ensuring the cooler’s ambient temperature remains below 3.3 degrees C (38 degrees F), with continuous temperature monitoring and at least a daily visual check of recorded data.
3. Inappropriate corrective action plan: The corrective action plan for the storage process CCP was inadequate to ensure that affected products do not enter interstate commerce. The FDA recommends that corrective actions include chilling and holding the cooked vacuum-packed fish sausages until a food safety evaluation assesses cumulative time and temperature exposures for potential pathogen growth, including Clostridium botulinum, and that any unsafe product is discarded.

Additional concerns
The FDA emphasized that vacuum packaging, as used for Eden F&C’s fish sausages, is considered reduced oxygen packaging (ROP), which prevents normal oxygen exchange and introduces the risk of Clostridium botulinum. Non-proteolytic strains of this bacterium can grow at temperatures as low as 3.3 degrees C (38 degrees F), necessitating strict temperature controls. The agency noted that the supplier’s cooking process at 75 degrees C (167 degrees F) and lack of product formulation details, including water activity, pH, or water phase salt, do not adequately control this hazard, further underscoring the need for stringent critical limits.

FDA action and next steps
At the conclusion of the inspection, the FDA issued a Form FDA-483, Inspectional Observations, to Eden F&C. The company responded on May 14, May 16, Aug. 4 and Aug. 5, 2024, with a revised HACCP plan and implementation records. However, the FDA found these responses inadequate to address the violations. The agency has requested a written response within 15 working days, including a revised HACCP plan, five consecutive days of monitoring records for five production date codes, and additional documentation to demonstrate compliance with the seafood HACCP regulation. Failure to correct these issues could result in further regulatory action, including refusal of the company’s products for entry into the United States and placement on import alert #16-120, allowing detention without physical examination.

The full warning letter can be found here.