| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502 Telephone: 510-337-6700 |
Department of Health and Human Services
WARNING LETTER
September 12, 2011 Ref: 2917015
VIA UPS
Takateru Kishii, Vice President and General Manager
The Cherry Company, Ltd
4461 Malaai Street
Honolulu, HI 96818
Dear Mr. Kishii:
We inspected your seafood importer establishment, located at 4461 Malaai Street, Honolulu, Hawaii, on July 12 – 21, 2011. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 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 CFR 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 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your dried shaved mackerel & scad, and dried shaved bonito imported from Japan are adulterated under Section 402(a)(4)of the Act, 21 U.S.C. § 342(a)(4), 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 are as follows:
- You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm imports dried shaved mackerel & scad, and dried shaved bonito and you do not have product specifications to address the hazards of histamine; pathogen growth and potential toxin formation including, for example, Clostridium botulinum and Staphylococcus aureus toxin formation; undeclared food allergens/food additives; and potential metal inclusion.
- You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the importation of your dried shaved mackerel & scad imported from Yamaki Co, Ltd of Iyo-City, Japan.
We acknowledge receipt of your response to the FDA-483 dated August 18, 2011. This response included a HACCP plan from Yamaki Co, Ltd of Iyo-City, Japan for the dried shave bonito. However, this HACCP plan does not address all the hazards and controls associated with this fish and fishery product (i.e., as discussed above).
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
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," seize 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 these violations. 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 CFR 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 written reply to the:
Food and Drug Administration
Attention: Darlene Almogela, Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502.
If you have any questions regarding this letter, please contact Sergio Chavez at (510) 337-6886.
Sincerely,
/S/
Barbara J. Cassens
District Director
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