Inspections, Compliance, Enforcement, and Criminal Investigations
Food Joy Fresh Seafood, Inc. 1/06/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Ave.
Jamaica, NY 11433
January 6, 2009
VIA FED EX
Mr. Mi Woo Kim
Food Joy Fresh Seafood, Inc.
5418 43rd Street
Maspeth, New York 11378-1004
REF: NYK 2009-07
Dear Mr. Kim:
We inspected your seafood processing facility, located at 5418 43rd Street, Maspeth, New York on August 27 & 28, 2008 and September 3 & 4, 2008. 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 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 this part, 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 raw, aqua cultured, Time Temperature Integrator (TTI) labeled, refrigerated, vacuum-packaged Hamachi Yellowtail fillets, are adulterated, 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 violations were as follows:
1. You must conduct 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 a HACCP plan that complies with 21 CFR 123.6. The HACCP 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's HACCP plan for Histamine species fish, which is the plan used for your raw, aquacultured, TTI-labeled, refrigerated, vacuum-packaged Hamachi Yellowtail fillets, does not list the food safety hazard of pathogen growth and toxin formation, including Clostridium botulinum.
Packaging conditions that reduce the amount of oxygen present in the package (e.g. vacuum- packaging) extend the shelf life of product by inhibiting the growth of aerobic spoilage bacteria. The safety concern with these products is the increased potential for the formation of C. botulinum toxin before spoilage makes the product unacceptable to consumers. In reduced-oxygen packaged products in which refrigeration is the sole barrier to outgrowth of nonproteolytic C. botulinum and the spores have not been destroyed (e.g. vacuum-packaged raw fish), FDA recommends that the temperature be maintained at 38°F (3 .3°C) or below from packing to consumption. To ensure that temperature abuse does not occur during transport, FDA recommends either monitoring 1) the internal temperature of the fishery product or the ambient temperature within the carrier continuously throughout transportation or 2) the adequacy of ice or cooling medium at the time of delivery.
Also, your HACCP plan's critical limits of (b)(4) for both the "Receiving" and "Storage" critical control points (CCPs) will need to be revised to adequately control the food safety hazard of pathogen growth and toxin formation, including C. botulinum as discussed above.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for Histamine species fish which is used for your raw aquacultured, TTI-labeled, refrigerated, vacuum-packaged Hamachi Yellowtail fillets lists a monitoring procedure and frequency at the "Storage" CCP that are not adequate to control histamines. Specifically, this HACCP plan lists a monitoring procedure of taking (b)(4). This frequency is not appropriate to ensure continuous monitoring of your refrigerated fishery products. Intermittent temperature checks as a monitoring procedure during extended refrigerated storage is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks.
FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. 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. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly.
3. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure of (b)(4) at the "Receiving" critical control point to control Histamine formation listed in your HACCP plan for Histamine species fish which is used for raw, aquacultured, TTI-labeled, refrigerated, vacuum-packaged Hamachi Yellowtail fillets.
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 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 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.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have questions regarding any issues in this letter, please contact Lillian Aveta at 718-662-5576.
Otto D. Vitillo
New York District