• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Number One Fish Market Inc. 06-Jun-07

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

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896


WARNING LETTER
NWE-21-07W

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

June 6, 2007

Robert J. McNeil, President
Number One Fish Market Inc.
2239 State Street
Hamden, CT 06517

Dear Mr. McNeil:

On May 2 and 3, 2007 we inspected your seafood processing facility, located at 2239 State Street, Hamden, CT 06517. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21 Code of Federal Regulations, Part 123 and the Current Good Manufacturing Practice regulation for foods, 21 CFR § Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR § 123.6(g), failure of a processor 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 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 canned pasteurized crabmeat is adulterated in that the product has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act and the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in the FDA's home page at www.fda.gov.

• You must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have 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 canned pasteurized crabmeat to control the food safety hazards of pathogens and toxin formation.

• You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR § 123.11(c). However your firm did not maintain sanitation monitoring records for the safety of water that comes in contact with food or food contact surfaces and the type and the condition and cleanliness of food contact surfaces from December of 2006 to present.

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 the 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 HACCP plan for canned pasteurized crabmeat or any 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 deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 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.

Please send your reply to the Food and Drug Administration, Attention: Anthony P. Costello, Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issue in this letter please contact Mr. Costello at 781 596-7716.

Sincerely,

/S/

Gail T. Costello
District Director
New England District Office