Inspections, Compliance, Enforcement, and Criminal Investigations
Sea Breeze Fish Market Inc 17-Mar-06
Department of Health and Human Services
Public Health Service
New York District
March 17, 2006
RETURN RECEIPT REQUESTED
Vincent J. Dimino, Vice President
Sea Breeze Fish Market, Inc.
541 9th Avenue
New York, NY 10018
Dear Mr. Dimino:
We inspected your seafood processing facility, located at 541 9th Avenue, New York, NY on January 30, 2006 through February 1, 2006. We found that you have a serious deviation from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your Scombroid (Histamine) related species of finfish including Tuna, Mahi-Mahi, Bluefish, and Spanish Mackerel is adulterated, 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 and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.
Your significant violation is as follows:
You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process and have and implement a written HACCP plan for each of these food safety hazards to comply with 21 CFR 123.6. The HAACP plan must list the food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard• is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm does not have a HACCP plan for Scombroid (Histamine) related species of finfish including Tuna, Mahi-Mahi, Bluefish, and Spanish Mackerel to control the food safety hazard of Scombrotoxin Histamine formation.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350 (d)) and our implementing regulation at 21 CFR 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301 (dd) of the Act (21 U.S.C. § 331 (dd). Our records indicate that, to date your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately.
Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternately, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HACCP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350(d) and 21 CFR Part 1, Subpart H.
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 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 list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Ms. Aveta at (718) 662-5576.
Joseph F. McGinnis
Acting District Director
New York District