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  5. Procesadora Marina De La Costa Oriental Del Lago C.A. - 690911 - 08/30/2024
  1. Warning Letters

WARNING LETTER

Procesadora Marina De La Costa Oriental Del Lago C.A. MARCS-CMS 690911 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Maria Gabriela Rincon Villasmil
Recipient Title
Director and Co-Owner
Procesadora Marina De La Costa Oriental Del Lago C.A.

Calle Rafael Urdaneta Casa
Nro S/N Sector Punta Iguana Sur
Santa Rita , Zulia
Venezuela

mariagr2004@hotmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

WARNING LETTER

Reference #690911

Dear Ms. Villasmil,

The U.S. Food and Drug Administration conducted a Remote Regulatory Assessment (RRA) of your seafood processing facility, Procesadora Marina De La Costa Oriental Del Lago C.A., located at Calle Rafael Urdaneta Casa, Nro S/N Sector Punta Iguana Sur Santa Rita, Zulia Venezuela on May 13, 2024 through May 17, 2024. During the remote assessment, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. To date, we have not received a response to the items discussed with you at the close of the assessment.

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 ready-to-eat (RTE) cooked refrigerated and frozen jumbo lump, lump, cocktail claw, claw, and blue crab meat products are 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 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant deviations are as follows:
1. You must have a HACCP plan that at 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 “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 HACCP plan for refrigerated and frozen crabmeat in reduced oxygen packaging (ROP) lists inadequate critical limits at the following critical control points (CCPs):

a. Your final product storage CCP lists critical limits for cooler and product temperatures and your label CCP lists critical limits for declaring crab that are not adequate to control non-proteolytic Clostridium botulinum (C. botulinum) growth and toxin formation during distribution. Your finished product of RTE crabmeat is packaged in airtight heat-sealed plastic containers which creates a reduced oxygen environment and introduces the hazard of C. botulinum. Non-proteolytic C. botulinum has a minimum growth temperature of (b)(4)°C ((b)(4)°F) which is below normal refrigerated distribution and thawing temperatures. Thus, temperature control such as refrigeration and freezing by itself is not adequate to prevent non-proteolytic C. botulinum growth and toxin formation once the product leaves your control and enters distribution. Frozen product should be frozen immediately after packaging and your HACCP plan should at the label CCP list a critical limit to ensure each individual ROP package is labeled with instruction to keep the product frozen and for proper thawing such as thaw under refrigeration immediately before use or removing product from packaging before thawing. Refrigerated product should have a time temperature indicator (TTI) attached to each individual product in ROP. The TTI should be designed to have a visual alert that indicates when product has been exposed to times and temperatures that may allow C. botulinum growth and toxin formation. Your HACCP plan should list additional CCPs for the use and attachment of TTIs per the manufacturer’s specifications in addition to your final product storage CCP. Additionally, high-pressure processing (HPP) by your customer in the U.S. will not alleviate the need for these controls in your HACCP plan. This crabmeat in ROP is subject to Import Alert #16-125 and will be detained if HACCP controls for C. botulinum growth and toxin formation are not properly implemented. See Chapter 13 of FDA’s Fish and Fisheries Products and Hazards and Controls guidance (Guide) for more information on controlling C. botulinum growth and toxin formation.

b. Your storage of the cooked crab cooling CCP list critical limits of cooling the cooked meat to (b)(4)°C in (b)(4) hours in the cooler and to (b)(4)°C in an additional (b)(4) hours. This critical limit is not adequate because it does not include cooling of crabs after cooking under fans to (b)(4)°C within (b)(4) minutes before being placed in the cooler for further cooling as part of the exposure time to control pathogen growth and toxin formation. Your critical limit should include the cooling outside of the cooler with the fans and in addition to the time inside the cooler. See Chapter 12 of the Guide for more information on cooling.

2. You must have a HACCP Plan that at 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 Precooked Refrigerated and Frozen Crab Meat HACCP Plan lists a monitoring procedure frequency of taking the cooler temperature every hour at your final product storage CCP that is not adequate to control pathogen growth and toxin formation as required by 21 CFR 123.6 (c)(4). Your monitoring procedure should list continuous time and temperature monitoring of the ambient cooler temperature with a visual check of the recorded data at least daily.

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 (e.g., revised HACCP plan and CCP monitoring records in English) 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.

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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.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 and the Current Good Manufacturing Practice regulation (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 via email to HFP-OCE-ConventionalFoods@fda.hhs.gov. If sending a response by mail, address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact HFP-OCE-ConventionalFoods@fda.hhs.gov and include reference #690911 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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

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