| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human ServicesFebruary 23, 2011
Warning Letter NYK-2011-17
VIA UPS
Chris H. Chon, President
Sea Express Inc.
5902 55th Street
Maspeth, New York 11378-3104
Dear Mr. Chon:
We inspected your seafood processing facility, located at 5902 55th Street, Maspeth, New York between December 9 and 15, 2010. 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, and the Current Good Manufacturing Practice (CGMP) 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 seafood products 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, the CGMP regulation for foods, 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 and you must have 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 raw Flounder for raw consumption by the consumer, to control the food safety hazard of parasites.
Your firm also receives, stores, and distributes refrigerated salmon for raw consumption. Please be aware that parasites may also pose a hazard reasonably likely in some aquaculture raised salmon which may need to be addressed in a HACCP plan.
2) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for “Histamine/C bot” dated December 18, 2010 lists a critical limit, (b)(4) at the “Processing/Storage” critical control point (CCP) that is not adequate to control histamine and Clostridium botulinum toxin formation. Specifically, your HACCP plan states you will be monitoring “Presence of Ice”; however, your HACCP plan does not list critical limits associated with presence of ice.
The “Corrective Action” at the “Processing/Storage” critical control point for in your HACCP plan for “Histamine/C bot” lists a temperature of (b)(4) while the “Critical Limit” lists a temperature of (b)(4). The temperature listed in your corrective action should be the same temperature as listed for your critical limit.
3) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, on December 9, 2010 your firm could not provide records of monitoring observations at the “Receiving” critical control point to control histamines listed in your HACCP plan for three Spanish Mackerel observed held in your firm’s walk-in cooler.
4) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not adequately monitor the following sanitation conditions:
Prevention of cross contamination from insanitary objects to food, food packaging materials, and food contact surfaces:
• On December 10, 2010, you were observed filleting ready-to-eat Yellowfin and bigeye tuna in your walk-in cooler fillet station. While a headed and gutted ready-to eat Yellowfin Tuna was on the plastic cutting board at this fillet station, you were observed picking up a pressurized hose from the concrete floor in the walk-in cooler and using the hose to haphazardly spray down the tuna and then walls of the walk-in cooler directly above the fillet station; water was noted splashing from the walk-in cooler walls and back down onto the plastic cutting board and Yellowfin Tuna. This tuna was subsequently cut into loins and placed in boxes for delivery to restaurants.
We acknowledge your December 18, 2010 response. However, it is inadequate because you do not state you will no longer wash down the fillet station to remove the tuna debris until you are finished, but only “If this is not preferred…” Surface contamination from the skin and on cutting surfaces is likely to be transferred to the edible portion of the fish during the cutting process. It is preferable to take measures to prevent splash from the wall from contacting product and food contact surfaces, and maintaining a clean work surface through rinsing.
• On December 9 and 10, 2010, the plastic curtains installed in the doorway of the walk-in cooler were observed to be covered in an accumulation of grime and food debris; a section of the plastic curtain was noted to be repaired with layers of uncleanable tape; employees and ready-to-eat fish products pass through these curtains and come in direct contact with them.
We acknowledge your December 18, 2010 response that you will replace the curtains; however, it is inadequate because you did not state that a correction has been made or provide a specific time for accomplishing the correction.
Safety of water that comes into contact with food or food contact surfaces:
• On December 9 and 10, 2010, a hose with a pressurized spray nozzle under continuous pressure was observed to be attached to the hose spigot located near the hand wash station without an adequate backflow prevention device installed between the hose and your firm's potable water system; the nozzle of the hose was noted to be sitting in pooled, stagnant water on the concrete floor in the firm's warehouse area on December 9, 2010.
Your December 18, 2010 response stated you will install adequate backflow prevention; however, it is inadequate because you did not indicate that a correction has been made or provide a specific time for accomplishing the correction.
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) 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. In your response, you should include documentation such as hazard analyses, revised HACCP plans, monitoring records, as well as other useful information that would assist us in evaluating your corrections. In addition, please also provide an explanation of how your firm is able to measure the cumulative time and temperature exposures above your temperature critical limits based on review of your monitoring records. 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.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
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: Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have questions regarding any issues in this letter, please contact Mr. Rugnetta at (716) 541-0324.
Sincerely,
/s/
Ronald M. Pace
District Director
New York District
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