Inspections, Compliance, Enforcement, and Criminal Investigations
Advanced Foods 7/12/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
WARNING LETTER NYK-2013-24
July 12, 2013
VIA UNITED PARCEL SERVICE
Mr. Roy S. Tucillo, Sr., President
Advanced Foods, Inc.
32 Urban Avenue
Westbury, NY 11590
Dear Mr. Tucillo:
We inspected your seafood establishment, located at 32 Urban Avenue, Westbury, NY 11590 on May 7, 2013 through May 29, 2013. 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 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(a)(2), every importer of fish or fishery products shall have and implement written verification procedures for ensuring that the fish and fishery products that they offer for import into the United States were processed in accordance with the requirements of 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 imported, frozen seafood products including, but not limited to, arrow tooth flounder, squid, whelk, breaded shrimp, and tilapia 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 violation was as follows:
- You must have and implement written verification procedures, that include product specifications and an affirmative step(s), for ensuring that the fish and fishery products you import into the United States were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2). However, your firm has no written verification procedures and did not implement an affirmative step for fishery products that you imported, including, but not limited to:
- Frozen cooked breaded shrimp that you imported from (b)(4),
- Frozen whelk meat that you imported from (b)(4),
- Frozen tilapia that you imported from (b)(4),
- Frozen squid that you imported from (b)(4), and
- Frozen arrow tooth flounder that you imported from (b)(4).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 verification records, 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 have listed all the violations at your facility. You are responsible for ensuring that your seafood importer operates in compliance with the Act, the seafood HACCP regulation (21 C.F.R. Part 123) and the Current Good Manufacturing Practice regulation (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your response to:
U. S. Food and Drug Administration
LCDR Frank Verni, Compliance Officer
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
If you have any questions regarding any issues in this letter please contact: LCDR Verni at (718) 662-5702.
Ronald M. Pace
New York District