Inspections, Compliance, Enforcement, and Criminal Investigations
Central Boeki USA Ltd 31-Jul-06
Department of Health and Human Services
Public Health Service
New York District
July 31, 2006
RETURN RECEIPT REQUESTED
Mr. Hiroyuki Tanida
Central Boeki U.S.A. Ltd.
5530 46th Street
Maspeth, NY 11378-2011
Dear Mr. Tanida:
We inspected your seafood processing facility, located at 5530 46`h Street on April 3, 2006, April 7, 2006, April 11, 2006, and April 12, 2006. 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), and the Current Good Manufacturing Practice regulation for Foods, 21 CFR 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). According, your vacuum packed farm raised raw yellowtail fillet supplied to you by [redacted] of [redacted] is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 violation was as follows:
You must conduct a hazard analysis to determine whether there are 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, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for vacuum packed farm raised raw yellowtail fillet to control the food safety hazards of scombrotoxin (histamine) formation and pathogen growth, specifically Clostridium botulinum.
Please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 7 (Scombrotoxin (Histamine) Formation), Chapter 12 (Pathogen Growth & Toxin Formation as a Result of Time/Temperature Abuse), and Chapter 13 (C. botulinum Toxin Formation) found at www.cfsan.fda.gov/~comm/haccp4.html for specific guidance, alternative control strategies, and sample HACCP plans for your review.
We may take further action if you do not promptly correct this violation. 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm 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 reply to the Food and Drug Administration, Attention: Laurence D. Daurio, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Mr. Daurio at (718) 662-5585.
Otto D. Vitillo
Acting District Director
New York District