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U.S. Department of Health and Human Services

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Enforcement Actions

Stuart’s Seafood Market, Ltd.11/14/12

  

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

Public Health Service
Food and Drug Administration
 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433  
 

November 14, 2012

WARNING LETTER NYK-2013-5


VIA UNITED PARCEL SERVICE

Bruce Sasso, President & Co-owner
Stuart’s Seafood Market, Ltd.
41 Oak Lane
Amagansett, New York 11930

Dear Mr. Sasso:

We inspected your seafood processing facility, located at 41 Oak Lane, Amagansett on October 10 and 15, 2012. 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, and  the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110  (21 CFR 123 & 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).  Accordingly, your refrigerated ready-to-eat pasteurized canned crabmeat and raw tuna are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby 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 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 refrigerated ready-to-eat pasteurized canned crabmeat to control the food safety hazard pathogen growth, including but not limited to, Clostridium botulinum.

2) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7).  However, your firm did not record monitoring observations at the receiving critical control point to control scombrotoxin (histamine) formation listed in your HACCP plan for raw tuna. For example, your HACCP plan requires a visual check for ice, or continuous temperature records during transport of your tuna products.  However, your monitoring records failed to show that you appropriately recorded either of these monitoring observations when receiving raw tuna.

We may take further action if you do not promptly correct these violations.  For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

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.  You should include in your response documentation such as HACCP and verification records, or 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.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, 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.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover  FDA’s costs for certain activities, including reinspection-related costs.  A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The July 2012 inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Pearl Street, Suite 100, Buffalo, New York 14202.  If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 846-6207 or E-mail at dean.rugnetta@fda.hhs.gov.

Sincerely,

/S/

Ronald M. Pace
District Director
New York District

 

cc:  Charlotte Klein Sasso, Secretary & Co-owner
       Stuart’s Seafood Market, Ltd.
       P.O. Box 1859
       Amagansett, New York 11930