Inspections, Compliance, Enforcement, and Criminal Investigations
Levittown Fish Market 27-Jul-04
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
July 27, 2004
Robert Tuccillo, Owner
Levittown Fish Market
146 Marine Street
Farmingdale, New York 11735
Dear Mr. Tuccillo:
On April 22-23, 2004, the Food and Drug Administration (FDA) conducted an inspection of your facility located at 7225 NW 25th Street, Suite 103, Miami, Florida. The inspection was conducted to determine your firm’s compliance with FDA’s seafood processing regulations (21 CFR 123). During our inspection, the FDA investigator observed deviations by your firm from the special requirements for imported products (21 CFR 123.12). You can find the seafood Hazard Analysis Critical Control Point (HACCP) regulations and the Federal Food, Drug, and Cosmetic Act (the Act) through links in FDA’s homepage at http://www.fda.gov.
The observations of concern to us are as follows:
1. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for fresh mahi mahi imported from Nicaragua.
In our letter to your purchaser, Gaston Illanes, dated September 18, 2003, a similar deviation was cited for fresh mahi mahi imported from Ecuador. At that time Mr. Illanes was president of Levittown Miami Corporation and was made fully aware of the regulations.
2. 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 had an inadequate affirmative step for fresh mahi mahi manufactured by Inversiones Nica Fish in Nicaragua because you had a copy of their written guarantee, but no copy of their HACCP plan in English.
A similar deviation was also brought to the attention of Gaston Illanes in our letter dated September 18, 2003, to your firm, Levittown Miami Corporation.
The above-identified deviations are not intended to be an all inclusive list of the deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.
You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, the FDA may detain your imported seafood products without examination. Under such conditions, the FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct these deviations, including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state your reason for the delay and the time frame within which the corrections will be completed.
Your reply relating to these concerns should be directed to the Food and Drug Administration, Attention: Diane J. Englund, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding the implementation of the seafood HACCP regulations, you may contact Ms. Englund at (407) 475-4741, for answers and/or directions toward guidance and sources of training in achieving compliance.
We look forward to working with you to achieve a successful HACCP plan.
Emma R. Singleton
Director, Florida District
cc: Gaston Illanes, Purchaser
Levittown Fish Market
7225 NW 25th Street, Suite 103
Miami, FL 33122-1708