Inspections, Compliance, Enforcement, and Criminal Investigations
Ranieri Fine Food Corporation 15-Mar-06
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REOUESTED
March 15, 2006
Anna Marie Lepore
Ranieri Fine Food Corporation
276 Metropolitan Avenue
Brooklyn, New York 11211
Dear Ms. Lepore
We inspected your seafood importer establishment, located at 276 Metropolitan Avenue on February 1, 7, 13, 15, 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 123). The specific requirements for imported fish and fish 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.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 assurance do not exit 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 as serious violation for 21 CFR Part 123, your imported canned tuna is adulterated under Section 402(a)(4) of the Act 21 U.S.C §342(a)(4)0, 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 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 regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for canned tuna manufactured by [redacted]
On March 4, 2006, responding to Compliance Officer Daurio's inquiry and the Inspectional Observations, FDA-483, issued on February 15, 2006, Mr. Angelo Ronconi, General Manager, faxed documents to Mr. Daurio relating to the canned tuna from [redacted]. These records, which are in [redacted], and issued by the [redacted] Health Ministry, are not adequate because they do not certify that the imported fish was processed in accordance with U.S. HACCP requirements.
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 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 listed 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: Laurence D. Daurio at the above address. If you have questions regarding any issues in this letter, please contact Mr. Daurio at 718-662-5585.
Joseph F. McGinnis
Acting District Director