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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bold Coast Smokehouse 05-Apr-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-11-06W

April 5, 2006

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Vincent Gartmayer, Owner
Bold Coast Smokehouse
Route 189
Lubec, ME 04652

Dear Mr. Gartmayer:

We inspected your seafood processing facility, located at Lubec, Maine on November 1 to December 7, 2005. 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 smoked salmon pate 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 violation is as follows:

You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for smoked salmon pate lists a monitoring procedure at the smoking critical control point that is not adequate, to control pathogen growth and toxin formation. Your monitoring procedure, [redacted] fails to list the specific frequency of how often monitoring activity will be performed. To control pathogen growth and toxin formation during hot smoking, FDA recommends continuous monitoring of time and temperature during the smoking operation, with periodic visual checks of the monitoring instrument itself.

In addition, your listed critical limit at the smoking critical control point indicates that you monitor ambient smoker chamber temperatures, rather than following FDA's recommendation to directly monitor internal temperature of the thickest portion of your three largest fish per batch. If you choose to monitor ambient smoker chamber temperature instead of monitoring internal fish temperature to control pathogen growth and toxin formation, your listed critical limit must be based on scientific studies which establish that smoker chamber temperatures of [redacted] will consistently ensure that appropriate internal fish temperatures are achieved for an adequate time period (e.g., at least 145°F for 30 minutes) to control pathogen survival through the cook.


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 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