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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pescamarca 8/2/10

 

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

Public Health Service
Food and Drug Administration
 College Park, MD


Warning Letter
LD. # 120308

August 2, 2010

VIA OVERNIGHT MAIL

Pescamarca
Sector Nuevo Palmarejo Ave No.1
La Canada De Urdanota
Venezuela

Dear Sir Madame:

On April 22 through 26, 2010, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States: Kingmar Seafood Corporation, located at 1301 NW 89th Court, Suite 206, Miami, Florida 33172-2317. That importer was found to be importing shrimp from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for your shrimp. Our evaluation of that HACCP plan (copy attached) revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

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 shrimp are adulterated, in that they have been prepared, packed, or held under insanitary 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 and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

We note the following deviations:

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 Part 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 foods safety hazard". However, your firm's HACCP plan for your shrimp lists inadequate critical limits at the "shrimp reception" critical control point to control aquaculture drugs. Specifically,  your plan lists that you will control aquaculture drugs via critical limits associated with certificates indicating appropriate use of drugs on every shipment. However, there is no indication that these certificates address the use of drugs that are not approved for use in the United States. Your plan does not ensure that drugs that are unapproved for use on fish intended for consumption in the United States will not be used.

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 the violation. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen 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 is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import ia16120.html.

In addition, we note that your HACCP plan includes a "Packing" critical control point that identifies the significant hazard of allergenic reaction to sodium bisulfite, and also indicates that every batch of shrimp will be analyzed to determine the sodium bisulfite concentration. Since your flow chart indicates that all products are treated with sulfites, the critical limit at this packing critical control point should list that all packaging materials will declare the presence of sulfite, and that each lot of packaging labels will be checked at receipt for the sulfite declaration on the labels.

This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, 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 the Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD
20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov

Sincerely.

/s/


Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition


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