Inspections, Compliance, Enforcement, and Criminal Investigations
Sushi On a Roll, Inc 12/16/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4401
RETURN RECEIPT REQUESTED
December 16, 2009
Jeffery R. Roberto, President
Sushi On A Roll, Inc.
1620 National Ave.
San Diego, Califomia 92113-1009
Dear Mr. Roberto:
We inspected your seafood processing facility, located at 1620 National Avenue, San Diego, CA on August 27, 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 CPR 123 & 110). In accordance with 21 CPR 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, the Sushi Rolls containing characterizing fishery products you process 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 and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CPR Part 110, to comply with 21 CPR 123.11(b). However, your firm did not with sufficient frequency:
a. Monitor the safety of water [21 CPR 123.11(b)(1)] that comes into contact with food or food contact surfaces, including water used to manufacture ice, as evidenced by a hose in your kitchen lacked a back-flow prevention device
b. Maintain hand washing and toilet facilities [21 CPR 123.11(b)(4)] , as evidenced by the observation of your three-compartment dishwashing sink that was prepared for dishwashing and sanitizing, but where the sanitization compartment lacked any detectable levels of sanitizing solution. Examination of this sink found that there was no sanitizer connected to the sanitizer dispensing system.
c. Protect food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants [21 CFR 123.11(b)(5)], as evidenced by the observation of:
• Milk-style crates filled with cleaned serving plates were stored directly on the floor of the walk-in cooler
• Four unprotected glass light tubes directly over a processing table in your kitchen
d. Maintain proper labeling, storage and use of toxic chemicals[21 CPR 123.11(b)(6)], as evidenced by two unlabeled chemical containers, one can of non-food grade spray lubricant, two spray cans of fabric protector, and one container of automobile mag wheel polish in your kitchen at your dishwashing station
e. Exclude pests from the food plant [21 CPR 123.11(b)(8)], as evidenced by the observation of:
• There were bird feces on both sides of the door that separates your kitchen from the dry storage room
• Ants were present in and on shelving in your dry storage room
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CPR 123.11(b), to comply with 21 CPR 123.11(c). However, your firm did not maintain sanitation monitoring records for 1) Safety of water that comes in contact with food or food contact surfaces; and 2) Storage and use of toxic chemicals required for the processing of sushi rolls.
3. 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CPR 123.3(1) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your film's HACCP plan for ready-to-eat sushi products containing "Shrimp, Tuna Salmon, Yellowtail, Eel" does not list the food safety hazard(s) of:
a) Pathogen growth at the receiving step for fresh refrigerated raw salmon used in salmon rolls.
b) Clostridium botulinum growth and toxin formation during the refrigerated thawing and storage of frozen vacuum-packaged raw fish for sushi rolls including yellowtail (Hamachi) and Yellowfin Tuna.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and frequencies that ensure compliance with the critical limit, to comply with 123.6(c)(4). However, your film's HACCP plan for ready-to-eat sushi products containing "Shrimp, Tuna Salmon, Yellowtail, Eel" lists a monitoring procedure and frequency at the Cool storage point that is not adequate to control histamine formation and pathogen growth. Specifically, the procedures and frequency that you have listed of a visual check of the walk-in cooler temperature three times daily for the cooler temperature not to exceed 40°F does not take into consideration product that remains in the cooler overnight or for extended non-operational periods. FDA recommends that when products are stored in coolers for extended time periods, especially during non-operational periods, that firms install equipment capable of continuously monitoring the storage times and temperatures; or adopt an equivalent level of control as part of the HACCP plan.
5. 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 have a HACCP plan that, at a minimum, lists the 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, as required by 123.6(a) and (b). However, your firm does not have a HACCP plan for the "California Roll" sushi roll which contains imitation crab meat to control the food safety hazard of pathogen growth during processing and storage. This product is not included in your HACCP plan for ready-to-eat sushi products containing "Shrimp, Tuna Salmon, Yellowtail, Eel".
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.
If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:
Acting Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612
Alonza E. Cruse
Director, Los Angeles District
cc: Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capital Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413