Inspections, Compliance, Enforcement, and Criminal Investigations
Central Boeki USA Ltd 24-Mar-05
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
March 24, 2005
Hitoshi Tanaka, President
Central Boeki U.S.A., Ltd.
5530 46th Street
Maspeth, New York 11378
Dear Mr. Tanaka:
On February 9 and 10, 2005, the Food and Drug Administration (FDA) conducted an inspection of your seafood importing and distribution facility located at the above address. The inspection was conducted to determine your firm's compliance with the FDA's seafood Hazard Analysis and Critical Control Points (HACCP) regulations for Fish and Fishery Products, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
During our inspection, the investigator observed serious deviations from the special requirements for imported fish and fishery products (21 CFR 123.12). In accordance with 21 CFR 123.6(g), failure of a processor to operate in accordance with the requirements of 21 CFR Part 123, renders the fish or fishery products of that processor adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 342(a)(4). You may find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.
The FDA investigator provided you with a copy of the Form FDA 483, Inspectional Observations, which presents his evaluation of your firm's performance regarding various aspects of the HACCP requirements. The deviations of concern to us include the following:
1. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR123.12(a)(2)(i). However, your firm does not have product specifications for frozen prepared, boiled, clams and frozen mackerel imported from [redacted]
2. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for frozen prepared, boiled, clams manufactured by [redacted] in [redacted] and frozen mackerel manufactured by [redacted] These seafood processors are not on the list provided by [redacted] authorities of seafood processors meeting the requirements of FDA HACCP regulations. Therefore you must implement one of the affirmative steps as specified by 21 CFR 123.12(a)(2)(ii)(A) through (F)
Please note that the above identified deviations were previously brought to the attention of Central Boeki U.S.A., Ltd. in our letter of May 23, 2001.
These deviations and the Inspectional Observations (Form FDA 483) that were presented to, and discussed with Mr. Hiroyuki Tanida, General Manager, at the conclusion of the inspection are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all fish and fishery products imported, processed, and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.
You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may detain your imported fish and fishery products without examination. Under such conditions, FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.
Please notify this office in writing within 15 working days of your receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their recurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
You should send your reply to Attn: Laurence D. Daurio, Compliance Officer, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issue in this letter, you can contact Mr. Daurio by telephone at (718) 340-7000 ext. 5585.
Jerome G. Woyshner
Enclosure: Form FDA 483 dated February 10, 2005