Inspections, Compliance, Enforcement, and Criminal Investigations
Hiroshi's Enterprises, Inc. 07-Jul-08
Department of Health and Human Services
Public Health Service
July 7, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-24
Charles H. Matsushima, President
Hiroshi's Enterprises, Inc.
736 Northeast Martin Luther King Blvd.
Portland, Oregon 97232-2743
Dear Mr. Matsushima:
We inspected your seafood processing facility, located at 736 Northeast Martin Luther King Blvd., Portland, Oregon, on April 29, 2008. 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 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 scombroid species products, such as Yellowfin tuna, 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 violations were as follows:
1. 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 scombroid species lists a critical limit, "Otherwise: No more than 4 hrs. Cumulative time for thawing and butchering," at the "Finished Product Storage" critical control point (CCP)that is not adequate to control the hazard of scombrotoxin formation during refrigerated storage. Specifically, your listed critical limit does not reference a maximum or minimum value, such as a maximum storage temperature or the adequacy of ice, which will ensure maintenance of proper holding temperatures during refrigerated storage. For more information on the hazard of scombrotoxin (histamine) formation, please refer to the Fish and Fisheries Products Hazard and Controls Guidance: Third Edition, Chapter 7, found at: http://www.cfsan.fda.gov/~comm/haccp4.html.
2. You must have a HACCP plan that at a minimum lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for scombroid species lists monitoring procedures at the "Receiving Fish" CCP that is not adequate to control scombrotoxin formation. Specifically, your HACCP plan for scombroid species to control the hazard of scombrotoxin formation lists a critical limit of "Temperature: Max. 40 degrees F" at the receiving CCP; however, none of the monitoring procedures in your HACCP plan reference the taking of product temperatures or any other temperatures. FDA recommends that for fish received refrigerated (not frozen), all lots be accompanied by transportation records that show that the fish were held at or below 40°F throughout transit.
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, your corrective action plans for scombroid species at the "Receiving Fish" and "Finished Product Storage" CCPs to control scombrotoxin formation are not appropriate in that they do not ensure that the cause of the deviation from the critical limit is corrected.
In addition, your corrective action plan for scombroid species at the "Finished Product Storage" CCP, which states "Return product to cooler or freezer" and "Make Sure Ice is Present," does not ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of a critical limit deviation.
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.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
Copy of FDA 483.
cc: OSDA, with disclosure statement