Inspections, Compliance, Enforcement, and Criminal Investigations
Stewart's Processing Corp. 11-Mar-08
Department of Health and Human Services
Public Health Service
New York District
March 11, 2008
RETURN RECEIPT REQUESTED
Gary C. Dake
Stewart's Processing Corp.
P.O. Box 435
Route 9 N Outer Church Street
Saratoga Springs, New York 12866
Dear Mr. Dake:
We inspected your seafood processing facility, located at Outer Church Street, Saratoga Springs, New York 12866 on January 3-4, 2008. We found that you have a serious violation 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 refrigerated ready-to-eat seafood salad and refrigerated ready-to-eat tuna salad are adulterated, in that they 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 violation was as follows:
You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement 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). However, your firm does not have a HACCP plan for refrigerated ready-to-eat seafood salad and refrigerated ready-to-eat tuna salad to control the food safety hazards of pathogen growth and toxin formation, and additionally, to control the food safety hazard of histamine formation in your ready-to-eat tuna salad.
At a minimum, you should consider inclusion of controls in your HACCP plan at the receipt and storage of ready-to-eat salads to ensure that products are maintained in a chilled state (at or below 40°F) throughout transit and during refrigerated storage. FDA recommends:
• For products in transit over four hours, all lots of seafood products received refrigerated (not frozen) be accompanied by transportation records that show that the products were held at or below 40°F throughout transit; and
• For refrigerated storage of seafood products, that you continuously monitor cooler temperatures with a digital time/temperature thermometer, with visual check of the instrument at least once per day.
You may refer to Chapters 7 (histamine formation) and 12 (pathogen growth and toxin formation) of the Fish & Fisheries Products Hazards and Controls Guidance for further information.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your products 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, your written HACCP plan and related 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 this violation.
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: Anna Alexander. If you have questions regarding any issues in this letter, please contact Anna Alexander at 718-662-5683.
Otto D. Vitillo