Sushi USA Inc. 4/19/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
April 19, 2013
Return Receipt Requested
Ms. Theresa I. Nam, Owner
Sushi USA, Inc.
16006 Industrial Drive
Gaithersburg, MD 20877-1414
Dear Ms. Nam:
We inspected your firm, a ready-to-eat (RTE) sushi manufacturer, located at 16006 Industrial Drive in Gaithersburg, MD on March 14, 18, 19, and 22, 2013.
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 fish and fishery products are adulterated, as they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the current edition of the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
Specifically, our inspection of your facility revealed the following seafood HACCP violations:
1.) You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you process to determine whether there are food safety hazards which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards which 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 your tuna, mackerel, escolar, salmon, shrimp, eel, tilapia, or California Roll (whitefish surimi) sushi products to control the food safety hazards of pathogen growth and toxin formation from time/temperature abuse and undeclared allergenic substances. Additionally, we suggest you refer to the tables in Chapter 3 of the 4th Edition of FDA’s Fish and Fishery Products Hazards and Controls Guidance (i.e., the Hazards Guide) to assess when conducting your hazard analysis, whether there are additional hazards associated with your products, your process and/or your packaging. Once you have identified any additional hazards, the Hazards Guide then provides references to the appropriate chapters which in turn provide information and assistance in selecting adequate controls for your products and processes.
Furthermore, you do not have adequate controls in place to monitor the temperature of your walk-in cooler where raw and RTE sushi products are stored nor the pH of cooked sushi rice that was observed on March 19, 2013 to have been stored at room temperature in your rice warmer for more than twelve hours.
2.) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor with sufficient frequency the following:
a. The condition and cleanliness of food contact surfaces, including utensils, as required by 21 CFR 123.11(b)(2). Your chef was observed on March 14, 2013 preparing seafood and non-seafood products with the same knives, cutting board, and gloves. He was observed using the same cloth towel and bowl of water to wipe equipment between seafood and non-seafood products. The knives were not washed or sanitized between use for seafood and non-seafood products nor before storing them on a rack overnight.
b. The prevention of cross-contamination, as required by 21 CFR 123.11(b)(3). Your chef was observed on March 14, 2013 failing to wash his hands or change gloves after leaving the processing room and touching equipment, such as cooler handles, carts, and a wet rag, before returning and touching RTE food ingredients and products. He was also observed using his mobile phone while making RTE food products without washing his hands or changing gloves.
c. The safety of water that comes into contact with food or food contact surfaces, as required by 21 CFR 123.11(b)(1). Your firm’s water source was not known.
3.) You must have an individual associated with your firm who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA, or is otherwise qualified through job experience, as required by 21 CFR 123.10. As of March 18, 2013, no one associated with your firm was found to have been adequately trained.
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.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the seafood HACCP regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-1(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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, as well as the remaining issues cited on the FDA-483, Inspectional Observations, issued to you on March 22, 2013. You should include in your response documentation such as a HACCP plan 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak at 410-779-5715 or email@example.com.
Baltimore District Office