Inspections, Compliance, Enforcement, and Criminal Investigations
Sushi on the Spot 08-Mar-05
Department of Health and Human Services
Public Health Service
Telephone : 425-486-8788
March 8, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-15
Jeffery T. Wickstrom, Owner
Sushi on the Spot
3901 Rose Hill Street
Boise, Idaho 83705
Dear Mr. Wickstrom:
On October 19, 2004, we inspected your seafood processing facility, located at 3901 Rose Hill Street, Boise, Idaho. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 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 to otherwise operate in accordance with the requirements of this part, renders the 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 the sushi products you produce in your facility are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act, the Seafood HACCP regulations and the Fish and Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001 (the Hazard Guide), through links in FDA's homepage at www.fda.gov.
The deviations are as follows:
1 . 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 plans for tuna and cold smoked salmon lists a monitoring frequency of checking cooler temperatures [redacted] that is inadequate to control pathogens. Specifically, on October 19-20, 2004, our investigator observed raw tuna, vacuum-packaged cold smoked salmon, and ready-to-eat sushi rolls in the cooler. These products require continuous monitoring of the cooler temperature to control the histamine formation (tuna), pathogen growth (sushi), and Clostridium botulinum (vacuum-packaged cold smoked salmon).
2 . You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c) . However, your firm did not maintain sanitation monitoring records for eight areas of sanitation that are required for the processing of your sushi products on April 10, 25, 27-30; June 2-30; July 1-6, 8-10, 15-31 ; August 20-21, 24, 26, 28-29 ; September 3-5, 7-8, 11-12, 18-19, 27; and October 3, 8-9, 18, 2004.
The eight areas of sanitation are as follows :
Safety of water
Condition and cleanliness of food contact surfaces
Prevention of cross-contamination from insanitary objects
Maintenance of hand-washing, hand sanitizing, and toilet facilities
Protection of food, food packaging material, and food contact surfaces from adulteration
Proper labeling, storage, and use of toxic chemicals
Control of employee health conditions
Exclusion of pests
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.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations . You may wish to include in your response documentation such as your revised HACCP plan or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations .
This letter may not list all the deviations at your facility . You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal, Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021 . If you have questions regarding any issue in this letter, please contact Ms. Elrand at (425) 483-4923 .
Charles M. Breen
Form FDA 483