Inspections, Compliance, Enforcement, and Criminal Investigations
Katies Seafood 1/08/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3126
January 8, 2009
RETURN RECEIPT REQUESTED
Mr. Keith Guindon, Owner
Katies Seafood Market
1902 Wharf Road
Galveston, Texas 77550
Dear Mr. Guindon:
We inspected your seafood processing facility, Katies Seafood Market located at 1902 Wharf Road, Galveston, Texas on December 4th through December 12th, 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 and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR § 123.6(g), failure of a processor of fish and fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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 mahi-mahi, amberjack, tuna, grouper, and red snapper 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 have a HACCP plan that, at a minimum, lists the critical limits (CL) that must be met, 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 entitled "Raw, Whole Fish" intended to control the food safety hazard of histamine in scombroid species of fish such as wahoo, amberjack, tuna, and mahi-mahi does not list critical limits at the "Receiving Boat" critical control point adequate to control histamine when your firm acts as a primary processor (i.e., receiving fish directly from the harvest boats). Your receiving critical control point does not address handling of fish on-board the harvest vessels.
• As a primary processor FDA recommends that your firm control the hazard of histamine by:
• Taking internal temperatures on a representative number of fish (a minimum of 12 or the entire lot if less fish are in the lot). The recommended safe internal temperatures vary with the length of time from capture:
• Conducting sensory evaluation on a representative number of fish in the lot, ensuring no more than 2.5% decomposition in the entire lot;
• Obtaining harvest vessel records that include the following information: method of capture, date and time of landing; estimated time of death of fish; air/water temperatures; method of cooling on board the vessel; date/time cooling began; cooling rate including any additional factors demonstrating adequate cooling, for example the internal temperature after 6 hours; storage controls; and date and time of off-loading. Please note that the example of the "harvest vessel record" provided to our investigator does not include all the necessary information to demonstrate appropriate handling practices on-board the boats to control histamine;
Or, as an alternative to the boat records:
• conducting histamine testing on a representative number of fish in the lot.
• As a secondary processor, your critical limits of "all species should be less than or equal to 40°F upon receipt" and your monitoring procedures listed as monitoring the product temperature of "[(b)(4)] out of 1000 lbs of lot" to control histamine at the "Receiving Truck" critical control point are not adequate to control histamine. FDA recommends, for example,
• Taking internal temperatures of fish only when receiving fish that have been in transit for short time periods of time (i.e., less than 4 hours). In addition, the monitoring procedures need to ensure that a representative number of fish temperatures are taken in order to demonstrate the overall condition of the entire lot. We suggest taking more than a temperature of [(b)(4)] in each 1000 lbs. in order to represent the condition of the entire 1000 lb. lot;
• Continuously monitoring temperatures throughout the entire duration of the transit period when fish are in transit for long periods of time. This is to ensure that no temperature fluctuations occurred during the transit period, exposing the fish to temperatures above 40°F for extended time periods. You may accomplish this by requiring time/temperature data records or some similar method of monitoring;
• Monitoring for the presence of adequate ice or cooling media when receiving fish on ice or cooling media.
2. You must implement the monitoring procedures, and record keeping system that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures listed in your HACCP plan at the "Receiving Boat" critical control point to obtain "certification from vessel that product was not caught in areas under the ciguatera fish poisoning (CFP) alert" to control ciguatera fish poisoning. Specifically, your firm did not have any receiving records from the harvest vessel to ensure that the red snapper (Lutjanus spp) and grouper were not caught in a CFP alert area.
3. 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, the corrective action plan in your "Raw, Whole Fish" HACCP plan lists actions at the "Storage" critical control point that are not appropriate to control histamine. Specifically, the actions listed in the plan associated with holding and evaluating product based on total time/temp exposures; and destroying the lot if time above 40°F exceeds 4 hours are not appropriate because your firm will be unable to implement these actions. Your monitoring procedure, as listed in your plan at this control point, is to monitor the amount of ice at the time of removal of raw product from the storage cooler. Consequently, your firm will have no information associated with temperatures and/or times, since you are only monitoring the amount of ice when removing product. Also, the adding of ice is inappropriate because this does not ensure that adulterated product does not enter into U.S. commerce.
For more information on the hazard of histamine, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition. You can find this Guidance on our web site at: http://www.cfsan.fda.gov/~comm/haccp4g.html
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 revised HACCP plans, receiving 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 deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP Regulation and the 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: Edwin Ramos, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Mr. Ramos at (214) 253-5218.
Reynaldo R. Rodriguez, Jr.
Dallas District Director