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U.S. Department of Health and Human Services

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Enforcement Actions

Pescaderia La Marinera del 23 SA de CV 1/24/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 2074

Warning Letter
Reference No. 267997

JAN 24, 2012

VIA OVERNIGHT MAIL

Juan Carlos Fuentes Santiago, Owner
Pescaderia La Marinera del 23 SA de CV
Manzana 7, Lote 2, Region 84
Puerto Juarez, Cancun
Mexico

Dear Mr. Fuentes Santiago:

We inspected your seafood processing facility, located at Manzana 7, Lote 2, Region 84 Puerto Juarez, Cancun, Mexico on September 22 and 23, 2011. During that 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, Part 123 (21 CFR 123).

That inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm.

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 yellowtail and other scombrotoxin (histamine) forming fish species 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 Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violation is as follows:

•  You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for your yellowtail and other histamine forming fish species to control the food safety hazard of scombrotoxin (histamine) formation. Our inspection revealed that you are a primary processor, receiving the scombrotoxin (histamine) forming species of fish directly from the harvest vessels. Consequently, your firm is responsible for receiving controls that ensure the fish were properly handled onboard the vessels, as well as adopting adequate controls during your firm's operations, to prevent or reduce to an acceptable level, the potential for scombrotoxin (histamine) development.

For more information related to the hazard of histamine, please refer to the 4th Edition of the Hazards Guide which can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as a copy of any HACCP plan or plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the plan, any verification records, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) 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 [21 CFR Part 123] 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, the Seafood HACCP regulations, and the current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to Food and Drug Administration, Attention: Maria Corpuz, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Product Adulteration Branch HFS-606, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Maria Corpuz via email at Maria.Comuz@fda.hhs.gov

Sincerely,

/s/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
 and Applied Nutrition