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  5. Rey de los Camarones S. A. - 695816 - 12/23/2024
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WARNING LETTER

Rey de los Camarones S. A. MARCS-CMS 695816 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jianwei Rong
Recipient Title
General Manager/Owner
Rey de los Camarones S. A.

Kilometer 9 Of The New Road to Leon
In Front of the New York Motel, Barrio Xavier Gruta
Ciudad Sandino, Managua
Nicaragua

(b)(6)
Issuing Office:
Human Foods Program

United States

December 23, 2024

WARNING LETTER

Re: # 695816

Dear Mr. Jianwei Rong:

On August 26, 2024 through August 30, 2024, the United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) inspection of your seafood processing facility, located at Kilometer 9 Of The New Road to Leon, In Front of the New York Motel, Barrio Xavier Gruta Ciudad Sandino, Managua, Nicaragua. During our assessment of your facility, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. To date, we have not received a response to the observations provided to 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 dried and salted sea cucumber 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 violations were as follows:

1. 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 HACCP plan for dried sea cucumber does not list one or more critical control points (CCP) that are necessary for each of the identified food safety hazards. Specifically, your HACCP plan for dried sea cucumber does include a CCP for drying of sea cucumber.

Your hazard analysis for dried sea cucumber states that the hazard of biological pathogen growth at the (b)(4) step requires a CCP to control this hazard. However, your HACCP plan does not identify a CCP for drying. Your firm dries sea cucumbers at either: a) (b)(4)°C ((b)(4)°F - (b)(4)°F) for (b)(4) days in a drying room; or b) on plastic screens in the sun for (b)(4) days on the roof of the facility during the summer. Your firm relies on sensory examinations of the sea cucumber after drying to determine when they are adequately dried, and you do not perform any water activity level testing of the finished product. Your firm did not have any studies performed or supporting documentation showing that these drying procedures are adequate to control relevant biological pathogens. You distribute your finished dried sea cucumber product at ambient temperatures to the U.S. with a shelf-life of (b)(4) months. Your HACCP plan should include a CCP at the Drying step to control the hazard of pathogenic bacteria growth and toxin formation, including Staphylococcus aureus.

Drying the product sufficiently to reduce the water activity to (b)(4) or below is critical to obtaining a safe final product. This value is based on the minimum water activity for toxin formation of Staphylococcus aureus. Achieving the above-mentioned water activity will also inhibit the growth of other microbiological hazards. Your firm should establish the drying parameters utilizing a scientific validation study to ensure that the final product will consistently achieve a water activity of (b)(4) or below. Once all the parameters are validated, the critical factors for achieving the established water activity of less than 0.85 should be included as Critical Limits in the HACCP plan.

In addition to achieving a safe water activity in your finished product, you must implement time and temperature controls to prevent Staphylococcus aureuss growth and toxin formation prior to achieving a water activity of (b)(4). FDA recommends that processing temperatures be maintained below 10°C (50°F) during processing and stored under refrigeration, either surrounded by ice or maintained below 4.4°C (40°F). In the absence of refrigeration, exposure to uncontrolled temperatures should be limited to 3 hours cumulatively if ambient temperatures exceed 21°C (70°F) at any point. When temperatures remain between 10°C (50°F) and 21°C (70°F) safe exposure times can be extended to 12 hours cumulatively.

2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of monitoring the location and status of the fishing areas for each batch of sea cucumbers that you receive by asking the fisherman about the fishing areas and checking with state and local authorities about the status of the areas at the Raw Material CCP to control environmental chemicals and pesticides listed in your HACCP plan for dried sea cucumber that you export to the U.S. The HACCP plan states that these monitoring procedures will be documented on the Reception Record. The HACCP plan also states that the firm will receive an INPESCA Letter that informs the firm that there is no pollution of marine waters where the sea cucumbers were obtained. A review of your firm’s Registro de Recepcion de Pepino de Mar (Registro de monitoreo de PCC) for sea cucumber that were received at your firm on 6/2/24 and 6/7/24, and later dried and exported to the U.S., indicated that you were only documenting an organoleptic exam of incoming sea cucumber and no information about the monitoring of the status of the fishing areas with the fisherman or state and local authorities was performed or documented. This document is the only record used to monitor the performance of this CCP. During the assessment, you were not able to provide copies of any of these INPESCA letters showing that the sea cucumbers were obtained from safe marine waters.

You should respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. 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 believe that your products are 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 dried and salted sea cucumber 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. Imports alerts can be found on FDA’s web site www.FDA.gov.

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 CGMP & PC rule (21 CFR Part 117) and Seafood HACCP regulation (21 CFR Part 123). 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: Rosemary Sexton, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (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 Rosemary Sexton via email at: Rosemary.Sexton@fda.hhs.gov. Please include reference # 695816 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D., M.B.A
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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