Inspections, Compliance, Enforcement, and Criminal Investigations
Blue Ribbon Fish Co. 11/3/08
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Ave.
Jamaica, NY 11433
November 3, 2008
VIA FED EX
Blue Ribbon Fish Co.
800 Food Center Drive
Entrance "E", Units 67-79
Bronx, New York 10474
REF: NYK 2009-04
Dear Mr. Samuels:
We inspected your seafood processing facility, located at 800 Food Center Drive Entrance "E", Units 67-79, Bronx, New York 10474 on August 11, 12 and 13, 2008. 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, 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 Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your refrigerated ready-to-eat pasteurized crab meat in hermetically sealed containers 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, 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 conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur,to comply with 21 CFR 123.6 (a) and (b). However your firm does not have a HACCP plan for refrigerated ready-to-eat pasteurized crab meat in hermetically sealed containers to control the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum growth and toxin formation.
To maintain the safety of refrigerated pasteurized crabmeat, FDA recommends that the products be held at temperatures below 40°F. Your firm should consider critical control points in your HACCP plan that will address receipt and storage of the crab meat to ensure proper temperature control. For example, at receiving your firm should include monitoring of ice or cooling media when products are received on ice or cooling media; or alternatively, monitoring temperatures when products are received refrigerated without ice or cooling media. When products are in transit for extended time periods under refrigeration, we recommend obtaining a continuous record of the cooler temperatures during the entire transit period.
At your storage critical control point, FDA recommends the use of a continuous monitoring device, such as a continuous temperature data logger, capable of providing a record of the temperatures on a 24 hour a day, seven day a week. In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. When stored on ice or cooling media, your firm should conduct a daily check of the adequacy of the ice or cooling media.
We may take further action if you do not promptly correct this violation. 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 this violation. 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 violations 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 Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, 158-15 Liberty Avenue, Jamaica, NewYork 11433. If you have questions regarding any issues in this letter,
please contact Lillian Aveta at 718-662-5576.
Otto D. Vitillo