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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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North Atlantic Traders Ltd 23-Oct-06

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, MA 02180
(781) 596-7700
FAX: (781)596-7896




WARNING LETTER
NWE-03-07W

Certified Mail
Return Receipt Requested

October 23, 2006

Robert M. Kliss, President and Owner
North Atlantic Traders Ltd.
175 Alley Street
Lynn, MA 01905

Dear Mr. Kliss:

We inspected your seafood processing facility, located at North Atlantic Traders Ltd., 175 Alley Street, Lynn, MA, on August 30-31, 200. We found that you have serious deviations from 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 to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of Part 12, this part, renders the fish and 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 fresh tuna products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may can find this Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

l. You must implement the record keeping system that you listed in your HACCP plan to comply with 21 CFR 123.6 (b). However, your firm did not implement the record keeping system that you listed in your HACCP plan for fresh tuna at the "brine tanks/cooling" critical control point (i.e., CCP) to comply with 21 CFR 123.6(b). Your HACCP plan lists at the brine tanks/cooling CCP that the firm will monitor the adequacy of the ice in the slurry twice daily and document the results on the production log.

2. You must have a HACCP plan that, at a minimum, lists the critical limit that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR Part 123.3(c) as"the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for fresh tuna lists critical limits at the receiving critical control point that are not adequate to control the food safety hazard of histamine formation, for a primary processor such as yourselves, receiving fish directly from the harvest vessels. Although your HACCP plan lists "Review of Harvest Vessel Receiving Record," you fail to list information on the record necessary to ensure that the fish were properly handled on-board the vessel. Harvest vessel records should include the following information: method of capture; date and time of landing; estimated time of death; air/water temperatures; method of cooling on board the vessel; date/time cooling began; cooling rate including any additional factors demonstrating adequate cooling, for example the internal temperature after 6 hours; storage controls; and date and time of off-loading. In addition, your plan does not include the recording of internal temperatures of the fish at off-loaded and the performance of a sensory examination of the fresh tuna for decomposition. Moreover, your critical limits for receipt of the fish at your facility (i.e., transported from the dock) associated with refrigerated transit and listed as "refrigerated truck" is inadequate because there is no temperature limit. Please refer to Chapter 7 of FDA's Fish and Fishery Products Hazards & Controls Guidance: Third Edition for information on strategies to control histamine.

We may take further action if you do not promptly correct these above violations. For instance, we may 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 any 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 ands 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 (212 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: Ann Simoneau, Compliance Officer, at the address noted above . If you have any questions concerning this matter, please contact Ms. Simoneau at (781) 596-7732.

Sincerely,

/S/

Gail T. Costello
District Director
New England District Office