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WARNING LETTER

Reference #633378

Dear Mr. Alfonso Perez:

The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, Nicamex Seafood, located at Rolter Carretera Norte, 2c Norte, 2c Oeste, 1c Norte, Barrio Domitila Lugo, Managua, Nicaragua on February 7 – 15, 2022. 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 (21CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. To date, your firm has not responded to the discussion items identified during the FFRA.

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 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 & 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 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 dried sea cucumber lists a critical limit, “(b)(4),” at the (b)(4) critical control point that is not adequate to control pathogenic bacteria growth and toxin formation. Specifically, the critical limit does not ensure that the maximum finished product water activity is 0.85 or below to control the food safety hazard of Staphylococcus aureus (S. aureus). Drying the product sufficiently to reduce the water activity to 0.85 or below is critical to obtaining a safe final product. This value is based on the minimum water activity for toxin formation of S. aureus. Achieving the above-mentioned water activity will also inhibit the growth of other microbiological hazards. FDA recommends that your firm establish the drying parameters utilizing a scientific validation study to ensure that the final product will consistently achieve a water activity of 0.85 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 S. aureus growth and toxin formation prior to achieving a water activity of 0.85. 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 recordkeeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not implement the recordkeeping system listed in your dried sea cucumber HACCP Plan. Specifically, on 02/08/2022, during the FRRA of your facility, the investigator requested HACCP monitoring records for the processing of your dried sea cucumbers that were shipped to the United States on 06/30/2021, 05/05/2021, and 04/21/2021. On 02/14/2022, you informed the investigator via email that you are not able to provide the requested records since these were not found in the files of your record collection center.

3. You must implement and maintain sanitation control records to comply with 21 CFR 123.11(c). However, you are not implementing sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests. Specifically, on 02/08/2022, the investigator requested for the sanitation monitoring records for the processing of dried sea cucumbers on 06/30/2021, 05/05/2021, and 04/21/2021. On 02/14/2022, the investigator received an email from the firm’s General Manager stating that he is not able to provide the requested records since he could not find these in the files of their record collection center.

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 revised HACCP plan or plans, 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 plan, 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: Alyssa Piontkowski, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (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 Alyssa Piontkowski via email at: Alyssa.Clendenin@fda.hhs.gov. Please include reference #633378 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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