November 5, 2024

WARNING LETTER

Re: CMS # 694846

Dear Mr. Yen Yi Chen:

On August 12, 2024 through August 16, 2024, the United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) inspection of your seafood processing facility, located at KM 106.5 Carretera Panamericana, Rivas, 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. We acknowledge receipt of your responses via email on August 23, 2024 and September 30, 2024. Your response included your revised HACCP plan for frozen whole fish and fillet (histamine) and realetd HACCP documentation, as evidence of your corrective actions. Our evaluation of your response revealed it was not adequate, as further described in this letter.

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 frozen mahi-mahi fillets in vacuum-packging 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 firm’s HACCP plan for frozen whole fish and fillet (histamine), including frozen mahi-mahi fillets in vacuum-packaging, that you export to the U.S. does not contain a critical control point (CCP) for storage to control the hazard of scombrotoxin (histamine) formation in the fish during storage over several days in bins of ice before processing and subsequent freezing.

2. 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 for frozen whole fish and fillet (histamine) does not list a critical limit (s) at:

a. Receiving CCP - to control histamines during transit to your facility. As a secondary processor of whole, eviscerated mahi-mahi fish received in bins of ice from a supplier, proper transit controls should be implemented to ensure the fish were held continuously either fully surrounded by ice or at or below 4.4°C throughout transit. Your HACCP plan should reflect the monitoring of mahi-mahi upon reception.

b. Labeling/Receipt of Labels CCP –to control the hazard of C. botulinum toxin formation during finished frozen mahi-mahi fillets in vacuum-packaging product storage by ensuring that all finished product labels contain appropriate “keep frozen thaw under refrigeration immediately before use” statements. A review of the label that you place on frozen, vacuum-packaged mahi-mahi fillets exported to the U.S. indicated that they did not have appropriate ‘Keep Frozen’ and thawing/handling instructions for customers.

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 frozen mahi-mahi fillets in vacuum-packging 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 # 694846 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