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U.S. Department of Health and Human Services

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Enforcement Actions

GMI European Food Distributors Inc. 30-Jul-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-24-07W

July 30, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Gregory Izydorczak, President
GMI European Food Distributors Inc.
27 Woodland Road
Berlin, Connecticut 06037

Dear Mr. lzydorczak:

We inspected your seafood processing facility, located at 27 Woodland Road, Berlin, Connecticut 06037 from April 25-27, 2007. 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). 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 ready-to-eat refrigerated seafood is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 are as follows :

You must implement the monitoring and verification procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).

However, your firm did not:

o Follow the monitoring procedure at the "Finished Product Cooler" critical control point to control pathogen growth and toxin formation listed in your HACCP plan for refrigerated seafood. Specifically, your HACCP plan states you will monitor your finished product cooler with a digital data logger; however, we observed during our inspection that there is no data logger in your finished product cooler, and

o Follow the monitoring and verification procedures at the "Receiving" critical control point to control pathogen growth and toxin formation listed in your HACCP plan for refrigerated seafood products. Specifically, your HACCP plan states that you will check the temperature at receipt and review verification records; however, our inspection found only three occasions between 11-1-06 to 4-25-07 that you recorded the temperature of the shipment.

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.

Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.

Sincerely,

/S/

Gail T. Costello
District Director
New England District