Inspections, Compliance, Enforcement, and Criminal Investigations
Jroll LLC dba Sushi On The Roll 11/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Dr.Cincinnati, OH 45237
VIA United Parcel Service
November 19, 2012
Kenneth M. Oppenheimer, President & Owner
Jroll L.L.C. dba Sushi On The Roll
985 Boardman Alley
Medina, OH 44256
WARNING LETTER CIN-DO 13-373419
Dear Mr. Oppenheimer:
We inspected your seafood processing facility, located at 985 Boardman Alley, Medina, OH on September 4 – October 1, 2012. 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 (21 CFR 123). 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 sushi seafood products 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 regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). Your firm did not follow the monitoring procedures at the following critical control points (CCP) acidification of rice, thawing of fish/raw shellfish, packaging and labeling, and finished product refrigerated storage to control pathogen growth, histamine formation, and allergens listed in your HACCP plans for “Raw Fish, Tuna, and Yellowtail Sushi Rolls Histamine Products”, “Cooked Fish/Shell Fish – Fishcake, Ichiban, Ebi, Eel, Smoked Salmon Sushi Rolls”, and “Tempura Battered Shrimp”. Specifically,
a. You do not check the pH of each batch of rice intended for wholesale sushi.
b. You do not continuously monitor thawing and finished product storage temperatures.
c. You do not perform a visual check of the cooler used for thawing and finished product storage twice per day.
d. You do not check ingredient labeling on every package of finished product.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard”. However, your firm’s HACCP plan for “Raw Fish, Tuna, and Yellowtail Sushi Rolls Histamine Products” list a critical limit at the packaging and labeling critical control point that is not adequate to control allergens. Specifically, your critical limit states that packaged product must be labeled indicating raw.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, the corrective action plan listed in your HACCP plans for “Raw Fish, Tuna, and Yellowtail Sushi Rolls Histamine Products”, “Cooked Fish/Shell Fish – Fishcake, Ichiban, Ebi, Eel, Smoked Salmon Sushi Rolls”, and “Tempura Battered Shrimp” at the thawing of fish/raw shellfish and finished product refrigerated storage critical control points to control pathogen growth and histamine formation are not appropriate. Specifically, your corrective action plans do not assure that the cause of the deviation is corrected.
Additionally, the corrective action plan listed in your HACCP plan for “Raw Fish, Tuna, and Yellowtail Sushi Rolls Histamine Products” at the thawing of fish and finished product refrigerated storage critical control points to control histamine formation is not adequate. Your corrective action plan states that cumulative time-temperature exposure will be evaluated to determine what action to take with the product. Cumulative time-temperature exposure is not an appropriate corrective action when the hazard of concern is scombrotoxin (histamine) formation.
4. You must monitor and document sanitation conditions, practices, and corrections during processing, to comply with 21 CFR 123.11(b) and (c). Since July 8, 2012, your firm has not monitored and documented the eight areas of sanitation listed below:
a) Safety of water;
b) Condition of food contact surfaces;
c) Prevention of cross-contamination
d) Maintenance of hand washing, hand sanitizing, and toilet facilities;
e) Protection from adulterants;
f) Proper labeling, storage, and use of toxic compounds;
g) Control of employees with adverse health conditions; and
h) Control of pests
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection. A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Reinspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. You should include in your response documentation such as HACCP plans, HACCP monitoring 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.
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164.
Toniette K. Williams
Acting District Director
cc: Charles Kirchner, Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399