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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Mike's Seafood 11-Jul-03

HHS Blue Logo gifDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

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

 


WARNING LETTER
NWE-19-03W

 

VIA FEDERAL EXPRESS

July 11, 2003

Jerry M. Brunick
Owner
Mikes? Seafood
2495 Friendship Road
Waldoboro, ME 04572

Dear Mr. Brunick:

We inspected your seafood processing facility, located at 2495 Friendship Road, Waldoboro, ME, on June 2, 2003. We found that you have a serious deviation from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21 Code of Federal Regulations, Part 123 (21 CFR 123). 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 this part, renders the fishery products processed there 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 ready-to-eat crabmeat product is adulterated, in that the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find this Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov.

The serious deviation observed was as follows:

-         You must have a HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for ready-to-eat crabmeat, to control for the food safety hazard of pathogens. Please note that this deficiency is a repeat observation from the last inspection conducted on December 17, 2001.

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

Please 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 this deviation. You should include in your response any documentation, such as your HACCP plan, or other useful information that would assist us in evaluating your corrections. You should also conduct hazard analyses for each seafood product you process to determine if further HACCP plans are required. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.

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 Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

You may direct your reply to Karen N. Archdeacon, Compliance Officer, at the address noted above. If you have any questions concerning this matter, please contact Ms. Archdeacon at (781) 596-7707.

Sincerely,
/s/
Gail T. Costello
District Director
New England District Office