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  5. Yeshua Bendito, C.A. - 693457 - 11/01/2024
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WARNING LETTER

Yeshua Bendito, C.A. MARCS-CMS 693457 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Willy Ocando
Recipient Title
General Manager
Yeshua Bendito, C.A.

Av 2 Nro 23-79 Barrio San Luis
San Francisco 4004, Zulia
Venezuela

yesbenca@hotmail.com
Issuing Office:
Human Foods Program

United States

WARNING LETTER

November 1, 2024

Re: CMS #693457

Dear Mr. Willy Ocando:

On June 10, 2024 through June 14, 2024, The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, Yeshua Bendito, C.A., located at Av 2 Nro 23-79 Barrio San Luis San Francisco, Zulia, 4004 Venezuela. During our assessment, we found that you had serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). At the conclusion of the assessment, the FDA investigator issued an FDA RRA Observations letter that lists the observations made during the assessment of your firm. To date, your firm has not responded to the items identified during the FRRA.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP) product is adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the HazardsGuide) through links in FDA's home page at www.fda.gov. The June 2022 Edition of the Hazards Guide can be found on our web site at: https://www.fda.gov/food/seafood-guidance-documents-regulatoryinformation/fish-and-fishery-products-hazards-and-controls

Your significant deviations are as follows:

1. You must conduct or have conducted a hazard analysis for your cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP) product that you produce to determine whether there are any food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm’s hazard analysis does not include the following hazards:

a. Natural Toxins and Environmental Chemicals hazards should be controlled at a Receiving crabs critical control point (CCP).

b. Clostridium botulinum toxin formation hazard should be controlled at a Finished Product Labeling CCP. Specifically, the 12 oz crabmeat distributed ROP frozen should include safe handling instructions. The label declares only “Keep Refrigerated” with no additional temperature recommendation (32°C-38°C). The frozen ROP products should declare: “Important, keep frozen until used, thaw under refrigeration immediately before use” and should not be distributed refrigerated.

2. You must have a HACCP plan for your cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP) product 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 cools the crabs (b)(4) and does not appear to consider the cumulative times between these two steps. The placement of the cooked crabs in the perforated plastic baskets for the purpose of cooling after cooking (b)(4) is considered significant handling. At the Crab Refrigeration CCP, the HACCP plan fails to list critical limits for the cooling of the cooked crabs at this step. In addition to holding the crabs prior to meat removal, this step finishes the cooldown of the crabs after the (b)(4) step. The plan should include critical limits assuring that the cumulative time for chilling the crabs to below 21.1°C (70°F) is less than 1 hour including the cooling during the (b)(4) step. A second critical limit should ensure that the crabs are continuously chilled from 21.1°C (70°F) to 4.4°C (40°F) or less in the subsequent 3 hours. The cooldown internal temperatures should be monitored hourly. This is captured in the hazard analysis but has not been carried over to the HACCP plan CCP.

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for your cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP) product, lists monitoring procedures “(b)(4)” and “(b)(4)” at the Crab Refrigeration Cooked CCP and Storage of Finished Product CCP, respectively, that are not adequate to control the food safety hazard of pathogenic bacteria growth and toxin formation. Specifically, these steps are both periods of refrigerated holding. Ambient cooler temperatures should be monitored during holding or storage periods with a continuous data logger with a daily review of the data to determine if critical limits have been exceeded.

For additional guidance of the identified food safety hazards, you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 4th Edition at Chapter 6 for Natural Toxins, Chapter 13 for Clostridium botulinum Toxin Formation, and Chapter 16 for Pathogenic Bacteria Survival Through Cooking.

Additionally, we offer the following comment:

Our investigator reviewed a May 28, 2023, certificate of analysis for all types of crabmeat that reported high levels of lead residues. Since your firm appears to analyze for environmental chemicals, you may wish to identify this as a reasonably likely food safety hazard in your HACCP plan. The introduction of unintended particulate residues renders the seafood product adulterated under Section 402(a)(4) of the Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your Hazard Analysis and HACCP plan for your cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP) product , five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. 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. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the Seafood HACCP regulation is Import Alert 16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123) and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Giselle Jordan, Compliance Officer, Office of Compliance & Enforcement/Office of Enforcement /Division of Produce & Imports Enforcement /Imports Enforcement Branch, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #693457 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D.
Acting Director, Office of Enforcement
Office of Compliance & Enforcement
Human Foods Program

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