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  5. Mariscos Perla Mar S. de R.L. - 682814 - 05/01/2024
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WARNING LETTER

Mariscos Perla Mar S. de R.L. MARCS-CMS 682814 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Kiara Trejo
Recipient Title
General Manager
Mariscos Perla Mar S. de R.L.

Carretera al Muelle de Cabotaje
La Ceiba, Atlántida
Honduras

Northoceanica.hn@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

May 1, 2024

WARNING LETTER

Reference CMS #682814

Dear Ms. Kiara Trejo:

The United States Food and Drug Administration (FDA) conducted a Foreign Regulatory Assessment (FRRA) of your seafood processing facility, Mariscos Perla Mar S. de R.L., located at Carretera al Muelle de Cabotaje, La Ceiba, Atlántida, Honduras, on January 22 - 26, 2024. During the inspection, 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). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response via email on February 14, 2024. Your response included a revised HACCP plans for frozen raw lobster meat bags and frozen raw conch fillets dated January 2024 and other HACCP related documents. However, 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 raw lobster head meat and frozen raw conch fillets 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 conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1). A “food safety hazard” is defined in 21 CFR 123.3(f) as a “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your HACCP plans for frozen raw lobster head meat and frozen raw conch fillets that are thawed in reduced oxygen packaging (i.e., ROP) do not identify Clostridium botulinum growth and toxin formation as a food safety hazard at the (b)(4) step. Your firm thaws the frozen raw lobster meat bags and frozen raw conch in closed plastic bags at temperatures between (b)(4)°F - (b)(4)°F for (b)(4) hours or longer until the internal temperature of the product reaches (b)(4)°F - (b)(4)°F. The conch and lobster units in the bags are unlikely to thaw at a uniform rate which can allow for deterioration of units that thaw more quickly and continue to be exposed to the described temperatures and allowing for potential C. botulinum growth and toxin formation. The times and temperatures for thawing are potentially unsafe and can also allow for a portion of the products to become adulterated due to decomposition or deterioration.

For additional guidance and control strategies, you may reference the Fish and Fishery –––––Products Hazards & Controls Guidance - June 2022 4th Edition at https://www.fda.gov/media/80637/download, Chapter 13 for Clostridium botulinum Toxin Formation and Table A-4 Appendix 4 Bacterial Pathogen Growth and Inactivation.

2. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). Specifically, the daily sanitation monitoring records obtained by our investigator do not provide coverage of prevention of cross-contamination from insanitary objects, protection of food and packaging material from adulteration, proper labeling, storage, and use of toxic compounds, and control of employee health conditions. We acknowledge receipt of your corrected sanitation monitoring record showing that you are now monitoring your conditions and controls for the exclusion of pests. However, your records and procedures should also be corrected to address the other sanitation conditions and controls.

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 HACCP plans for frozen raw lobster head meat and frozen raw conch fillets, 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 with English translations) 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, 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 Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #682814 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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