Inspections, Compliance, Enforcement, and Criminal Investigations
Seaport Fish Company
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
RETURN RECEIPT REQUESTED
Date: October 14, 2009
Richard S. Pettigrew
Seaport Fish Company LLC
13 Sagamore Road
Rye, New Hampshire 03870-6109
Dear Mr. Pettigrew:
We inspected your seafood processing facility, located at 13 Sagamore Road, Rye, NH on July 23, 28, 31, 2009. 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 fresh tuna, cooked lobster meat and smoked salmon products are adulterated, in that they may have been prepared, packed, or held under insanitary conditions whereby they 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 were as follows:
1 You must conduct 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). Specifically, your firm does not have HACCP plans for cooked lobster meat and smoked salmon to control the food safety hazard of pathogen growth and potential toxin formation.
2 You must implement the monitoring procedures that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure of recording the internal temperature/checking for the presence of ice at the critical control point of receiving to control the hazard of scombrotoxin formation listed in your HACCP plan for fresh tuna.
3 You must have a HACCP plan that at a minimum lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c). However, your firm's HACCP plan for fresh tuna lists a monitoring frequency of (b)(4) at the critical control point of raw material storage that is not adequate to control the hazard of scombrotoxin formation. Intermittent temperature monitoring during extended storage periods is inadequate because this frequency does not ensure that proper temperatures were maintained between those checks. For example, intermittent temperature checks will provide no temperature records during weekends and other times when the facility is not in operation. Alternatively, FDA recommends that firms use equipment capable of continuously monitoring and recording temperatures on a 24 hour a day/7 day a week basis, with a daily check of the temperature record and a daily check of the equipment.
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: Anthony P. Costello. If you have questions regarding any issues in this letter, please contact Mr. Costello at 782 596-7716.
John R. Marzilli
New England District