Inspections, Compliance, Enforcement, and Criminal Investigations
Columbus Fish and Seafood, LLC 18-Aug-06
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
August 18, 2006
Frank Gonzalez, President
Columbus Fish and Seafood, LLC
5249 Trabue Road
Columbus, OH 43228-9564
Dear Mr. Gonzalez:
We inspected your seafood processing facility, located at 5249 Trabue Road, Columbus, OH 43228-9564 violations of the seafood Hazard Analysis and on June 19-22, 2006. 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 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 pasteurized crabmeat, and fresh Marlin, Escolar, Mahi, Wahoo and Snapper (red) whole or fillet 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:
Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for canned pasteurized crabmeat at the Critical Control Point (CCP) of receiving to control the hazard of pathogens is not appropriate. Specifically, your HACCP plan for pasteurized crabmeat lists a corrective action for the significant hazard of pathogens, which includes Clostridium botulinum (C. botulinum), at the CCP of receiving as "check seal, reject, recool". The HACCP plan did not specify the criteria for "reject" vs. "recool". The "recool" corrective action does not: eliminate the hazard from the product; prevent recurrence; or assure any/all product subjected to temperatures capable of allowing microbiological growth and toxin production does not enter commerce.
You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm's HACCP plan for pasteurized crabmeat lists a monitoring procedure at the receiving CCP that is not adequate to control the hazard of pathogens, including, but not limited to C. botulinum growth during transit. For example, your HACCP plan for pasteurized crabmeat does not address in-transit monitoring of temperature and/or time for the control of pathogens at the receiving CCP. This may be accomplished through continuous monitoring of the ambient or product temperature or checking on the adequacy of ice or other coolant. A continuous temperature log would allow you to make decisions regarding corrective action; whether to reject or rapidly cool temperature abused product.
Likewise, your HACCP plan for Fresh Histamine Fish - Tuna, Marlin, Escolar, Mahi, Wahoo lists a monitoring frequency that is not adequate to control the hazard of histamine formation at the storage CCP. The plan lists a critical limit of no more than four hours over 40 degrees. Your monitoring procedure for this critical limit lists the frequency for checking this temperature as "2x" daily. This frequency does not ensure adherence to the critical limit, provide enough information to perform an adequate investigation or ensure the corrective actions specified in the HACCP plans are adequate if an excursion was discovered. If you monitor "icing", as indicated by your HACCP plan, your critical limits and corrective action should be set accordingly.
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, 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: Stephen J. Rabe, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700 ext 163.
Carol A. Heppe