Inspections, Compliance, Enforcement, and Criminal Investigations
Tucson Fruit and Produce 22-Sep-06
Department of Health and Human Services
Public Health Service
Southwest Import District
Via Fed Ex
REF: WL 002-SWID-2006
Mr. Norman F. Thomas, CEO
Tucson Fruit and Produce
810 East 17th Street
Tucson AZ 85702
Dear Mr. Norman F. Thomas
We inspected your seafood importer establishment, located at 810 East 17th Street, Tucson A2 857702 on September 6, 2006. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HAOCP) 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 Yellowtail Amberjack are adulterated under Section 402(a).(4)of the Act (21 U.S.C. §.342(a)(4)), 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 violations were as follows:
You must have and implement written verification procedures for ensuring that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR §123:12(a)(2)(i)&(ii). The procedures shall list, at a minimum: (i) product specifications that are designed to ensure that the product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or have been processed under insanitary conditions; and (ii) affirmative steps as identified in the regulation. However, your firm does not have a product specification sheet or an adequate affirmative step for the fresh yellowtail amberjack manufactured by Mariscos Pez Grande of Guaymas, Mexico. At the time of the inspection your firm supplied FDA a copy of a Letter of Gaurentee but did not have a copy of the foreign firm's HACCP plan.
The HACCP plan which you later supplied to FDA on 9/14/2006 was reviewed and found to be inadequate in that it identified no critical control points for the hazard of histamine which is a hazard likely to occur in yellowtail amberjack and other histamine producing fish species.
We may take further action if you do not promptly correct these violations. 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 reply to the Food and Drug Administration, Attention: Brian Ravitch, Compliance Officer, 2320 Paseo De Las Americas, Suite 200, San Diego, California 92154. If you have questions regarding any issues in this letter, please contact Brian Ravitch at (619) 661-3250 ext.103.
Robert J . Deininger
Southwest Import District