Inspections, Compliance, Enforcement, and Criminal Investigations
Tony & Sons Seafood Corp. 18-Jul-08
Department of Health and Human Services
Public Health Service
New York District
July 18, 2008
RETURN RECEIPT REQUESTED
Sei Hoon Lei, Owner
Tony & Son Seafood Corp.
134-01 33rd Avenue
Flushing, New York 11354
Dear Mr. Lei:
We inspected your seafood processing facility, located at 134-01 33rd Avenue, Flushing, New York 11354 on March 12-13, 17 and 19, 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 toxin formation.
Once you have conducted a hazard analysis for your refrigerated ready-to-eat pasteurized crab meat product, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc. to ensure that the food safety hazards are controlled. For example, your hazard analysis should consider the hazard of pathogen growth and toxin formation, specifically Clostridium botulinum toxin formation, which is a reasonably likely hazard associated with this product. Preventative measures should likely be implemented at receipt and during refrigerated storage to ensure that the product is continuously maintained at or below 40°F. For example, at receiving your firm should consider monitoring the presence of ice or cooling media if product is received on ice or cooling media; or monitoring that temperatures were adequately maintained during transit, if product is shipped to you under refrigerated conditions.
Your firm should also consider a means to ensure that adequate storage temperatures are continuously maintained by monitoring the presence of ice or cooling media daily; or monitoring the temperatures on a continuous basis. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated 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.
If you choose to include corrective actions in your HACCP plan, your listed actions must be appropriate and must be consistent with your monitoring procedures. For example, if your monitoring procedure is to monitor the presence of ice at receiving and not ambient temperatures, your corrective action should not include an assessment of exposure time at ambient temperatures.
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 U.S. Food and Drug Administration, New York District, 300 Hamilton Ave., White Plains, NY 10601, Attention: Richard T. Trainor, Compliance Officer, HFR-NE140. If you have questions regarding any issues in this letter, please contact Mr. Trainor at (914) 682-6166 ext. 34.
Otto D. Vitillo