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  5. Procesadora Vikingo C.A. - 672307 - 03/06/2024
  1. Warning Letters

WARNING LETTER

Procesadora Vikingo C.A. MARCS-CMS 672307 —

Product:
Food & Beverages
Recipient:
Recipient Name
Milagros Higuera
Recipient Title
General Manager
Procesadora Vikingo C.A.

Av. 3 Y 4 Con Calle 13 Y 14 Pb, Sector El Rosado
La Canada De Urdaneta 4033, Zulia
Venezuela

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

March 6, 2024

WARNING LETTER 672307

Dear Ms. Higuera,

The U.S. Food and Drug Administration (FDA) performed a voluntary Remote Regulatory Assessment (RRA) of your Procesadora Vikingo C.A. facility located at Av. 3 Y 4 Con Calle 13 Y 14 Pb, Sector El Rosado, La Canada De Urdaneta, Zulia, 04033, Venezuela from September 11, 2023 through September 15, 2023. The FDA investigator evaluated your Hazard Analysis of Critical Control Point (HACCP) program as required under regulations found in 21 Code of Federal Regulations (21 C.F.R.), Part 123 (21 CFR 123) for the seafood products (refrigerated cooked, ready-to-eat (RTE) crabmeat) you manufacture. This assessment revealed your seafood products are deemed to be adulterated according to the Federal Food, Drug and Cosmetic Act (the Act), section 402(a)(4) because they have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

At the conclusion of FDA’s remote inspection, the FDA investigator provided a list of observations to Mayzuly Rodriguez, International Commercial Agent. The seafood HACCP violations include:

1. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogens when your process for cooked, RTE crabmeat deviated from your critical limit at the '(b)(4)’ critical control point. According to your monitoring records (b)(4) your firm cooked batches of crabs at (b)(4) minutes. A (b)(4) time of (b)(4) minutes is below your firm’s listed critical limit of (b)(4) minutes for this CCP and no corrective actions were performed. All crabs cooked on these days were processed and distributed to the U.S.

2. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c))(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for refrigerated, cooked, RTE crabmeat does not list the food safety hazard of undeclared allergens. Blue crabs are identified as a “major food allergen,” and as such, processors of crabs must include controls in their HACCP plan that ensure products are properly labeled.

3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). 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, your firm’s HACCP plan for refrigerated, cooked, RTE crabmeat does not list the critical control point of ambient cooling for controlling the food safety hazards of pathogen growth. After cooking, you cool crabs at ambient temperature for approximately (b)(4) minutes. FDA recommends that processors ensure the internal temperature of the product is at or below 4.4° C (40° F) prior to handling or when products are significantly handled that internal temperature are below 21°C (70°F) within 1 hour and below 4.4°C (40°F) within the subsequent 3 hours. As such, FDA recommends you include a critical control point for ambient cooling and monitor the time and product temperature to ensure the product reaches an internal temperature below 21°C (70°F) within 1 hour or combine the ambient (b)(4) step with the refrigerated (b)(4) critical control point.

4. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) 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, your firm’s HACCP plan for refrigerated, cooked and RTE crabmeat lists critical limits, “(b)(4)” at the Cooked Crab Refrigeration critical control point. These are not adequate to control pathogen growth. Specifically, your firm temporarily stores cooked crabmeat in refrigerated storage prior to picking and packing the crabmeat. See FDA recommendations above for information on time/temperature prior to handling.

5. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for refrigerated, cooked and RTE crabmeat lists a monitoring frequency of “(b)(4)” at the Finished Product Storage critical control point that is not adequate for your cooked crabmeat that you store and distribute refrigerated. FDA recommends that refrigerated temperatures are monitored continuously using a continuous monitoring device throughout storage with a visual check of the monitoring device at least once per day.

6. Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure that affected product is not entered into commerce and the cause of the deviation was corrected. Specifically:

  • Your HACCP plan for fresh and frozen precooked crab meat lists a corrective action at the Cooking CCP of ‘(b)(4).’ This corrective action does not ensure that the cause of the deviation was corrected.
  • Your HACCP plan for fresh and frozen precooked crab meat lists a corrective action at the Cooked Crab Refrigeration CCP of ‘(b)(4).’ This corrective action does not ensure that affected product is not entered into commerce and that the cause of the deviation was corrected.

The above violations are not intended to be an all-inclusive list of violations of the seafood HACCP regulations. It is your responsibility to ensure that you are in compliance with section 402(a)(4) of the Act and the implementing regulation in 21 CFR part 123.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food products you manufacture for which you appear to be in violation of section 402 of the Act. We may place the foods you manufacture on detention without physical examination (DWPE) when you ship the products to the United States. You can find DWPE information relating to this Import Alert #16-120 “Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP” at http://www.accessdata.fda.gov/cms_ia/ialist.html.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections and any additional supporting information that you wish to supply relevant to your compliance with the seafood HACCP regulations. If you believe that the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to the Food and Drug Administration, Attention: Kari Batey, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at kari.batey@fda.hhs.gov. Please reference CMS No. 672307 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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