Inspections, Compliance, Enforcement, and Criminal Investigations
LCDG Enterprise 12-Dec-06
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
December 12, 2006
Our Reference: FEI 1000440676
Lourdes C. de Guzman, Owner
2112 Waterhouse Street
Honolulu, Hawaii 96819
Dear Mrs. de Guzman:
We inspected your seafood importer establishment, located at 2112 Waterhouse Street, Honolulu, Hawaii, on September 15, and 18, 2006. 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 l23). 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 of 21 CFR Part 123, your smoked and boiled fish and fishery products are adulterated under Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)J, 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 violation was as follows:
You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform affirmative steps for smoked herring, smoked mackercl, and boiled roundscad manufactured by [redacted]
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 C21 U.S.C. § 381 (a)], including placing them on "detention without physical examination," seize your products 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 reply to the Food and Drug Administration, Attention: Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding any issues in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Lassens
San Francisco District