Northern Boulevard Corporation dba Despana Brand Foods 7/7/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158 - 15 Liberty Avenue Jamaica, New York 11433-1034

July 7, 2011

Warning Letter NYK-2011-27

VIA UPS

Marcos Intriago, President
Northern Boulevard Corporation
dba Despana Brand Foods
86-17 Northern Blvd
Jackson Heights, New York 11372

Dear Mr. Intriago:

We inspected your wholesale distribution facility, located at 86-17 Northern Blvd, Jackson Heights, New York, on April 18 through April 26, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). 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).

As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).

Accordingly, your refrigerated, ready-to-eat, dry cured tuna (Mojama) in vacuum packages and for refrigerated, ready-to-eat white anchovy fillets in vinegar and oil 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 & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1) You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product 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 refrigerated, ready-to-eat, dry cured tuna (Mojama) in vacuum packages and for refrigerated, ready-to-eat white anchovy fillets in vinegar and oil in reduced oxygen reduced packages to control the food safety hazards of scombrotoxin formation (histamine) and pathogen growth and toxin formation including Clostridium botulinum due to time/temperature abuse.

2) You must implement an affirmative step which ensures the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, the affirmative step your firm implemented is not adequate to fulfill the requirement. Your firm obtains a foreign government sanitary certificate for every lot of refrigerated, ready to eat, dry cured tuna (Mojama) in vacuum packages; refrigerated, ready-to-eat white anchovy fillets in vinegar and oil in oxygen reduced packages; cod; anchovies (canned, shelf stable); squid; and octopus imported from Spain; however, the certificate does not certify that the imported fish or fishery products were processed in accordance with the United States' Seafood HACCP regulation, 21 CFR Part 123.

We may take further action if you do not promptly correct these violations. 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", seize your product(s) and/or enjoin your firm from further violating the Act.

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 violations. In your response, you should include documentation such as hazard analyses, revised HACCP plans, monitoring records, as well as other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
 

This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.

Please send your reply to the Food and Drug Administration, Attention: LCDR Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have questions regarding any issues in this letter, please contact LCDR Jackson at (718) 662-5711.

Sincerely,

/S/
Ronald M. Pace
District Director
New York District
 

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