Inspections, Compliance, Enforcement, and Criminal Investigations
Central Boeki California, Ltd 18-Sep-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
September 18, 2006
Mr. Hitoshi Tanaka, President
Central Boeki California Ltd.
865 Sandhill Ave.,
Carson, CA 90746-1210
Dear Mr. Tanaka:
The United States Food and Drug Administration (FDA) inspected your seafood importer establishment, located at 865 Sandhill Ave., Carson, CA 90746-1210 on April 19, 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 C.F.R. Part 123). The seafood HACCP regulations were issued pursuant to Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 342(a)(4). In accordance with 21 C.F.R. 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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). You can find the Act and the seafood HACCP regulations through links in FDA's home page at http://www.fda.gov.
As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. The specific requirements for imported fish and fishery products are set out in 21 C.F.R. 123.12. In accordance with 21 C.F.R. 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 C.F.R. Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 C.F.R. Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and will be denied entry. Because our inspection identified serious violations for 21 C.F.R. Part 123 with respect to your Prepared Scallops, your Prepared Scallops fishery product is adulterated under Section 402(a)(4)of the Act, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Your significant violation was as follows:
You must implement an affirmative step which ensures that the fish and fishery products you offer for import are processed in accordance with the seafood HACCP regulation, to comply with 21 C.F.R. 123.12(a)(2)(ii). Affirmative steps may include any of the following:
A. Obtaining from the foreign processor the HACCP and sanitation monitoring records required by this part that relate to the specific lot of fish or fishery products being offered for import;
B. Obtain either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of the Seafood HACCP regulations;
C. Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of the Seafood HACCP regulations;
D. Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product was processed in accordance with the requirements of the Seafood HACCP regulations;
E. Periodically testing the imported fish or fishery product, and maintaining a copy on file in English, of a written guarantee from the foreign processor that the imported fish or fishery product was processed in accordance with the requirements of the Seafood HACCP regulations;
F. Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.
These are the kinds of measures that prudent importers already take. HACCP provides a systematic way of taking those measures that demonstrate to the FDA, to your customers, and to consumers that you purchase your imported seafood products from foreign suppliers who routinely practice seafood safety by design, and are in compliance with the U.S. food laws and regulations.
Your firm,however, did not perform an affirmative step for Prepared Scallops manufactured by [redacted] in [redacted]. During the inspection, you provided us with a March 17, 2005, letter from the foreign processor, which appears to be a letter of guarantee from the foreign processor. This document is not an adequate affirmative step. Pursuant to 21 C.F.R. 123.12(a)(ii)(D), a letter of guarantee from a foreign processor must be accompanied by a copy, in English, of the foreign processor's HACCP plan currently implemented by the processor to meet the requirements. In addition, this letter does not state that the processor is processing the Prepared Scallops in accordance with the Seafood HACCP Regulation, 21 C.F.R. Part 123.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seizing your product(s), and/or enjoin your firm from further violating the Act.
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 this violation. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, 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 seafood importer establishment operates in compliance with the Act and the Seafood HACCP Regulation (21 C.F.R. Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Please send your reply to:
Food and Drug Administration,
Attention: J. Lawrence Stevens,
Director, Import Operations Branch
Los Angeles District
222 West 6th Street, Suite 700
San Pedro, CA 90731
If you have questions regarding any issues in this letter, please contact Ruth P. Dixon, Compliance Officer at (310) 971-2299.
Alonza E. Cruse
Los Angeles District Office