Inspections, Compliance, Enforcement, and Criminal Investigations
Fish Busterz L.L.C 29-Aug-07
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
August 29, 2007
Mr. Charles H. Renier, Manager/Owner
Fish Busterz L.L.C.
6840 Front Street
Stock Island, Florida 33040
Dear Mr. Renier:
We inspected your seafood processing facility, located at 7001-Shrimp Road, Key West, Florida 33040 on April 2-3, 2007. 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.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 other wise 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 scombroid-forming species/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:
" You must have a HACCP plan that, at a minimum, lists the critical limits that must be met,to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR Part 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 (CCP)to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."
However, your firm's HACCP plan for"SCOMBROTOXIC FISH"(i.e.: Wahoo,amberjack, mahi-mahi, and king mackerel) lists a critical limit, "Temp of fish to [redacted] degrees or less", "Sensory evaluation of each shipment", and "Histamine type fish to be fully covered and surrounded with ice or chemical cooling media"at receiving the critical control point that is not adequate to control scombrotoxin formation, for a primary processor. such as yourself, receiving fish directly from the harvest vessels. Your HACCP plan currently lists controls at the receiving [redacted] as a secondary processor. As a primary processor, in addition to checking the internal temperature of the fish and sensory examination, FDA recommends one of two options for controlling the scombrotoxin hazard at receiving: (1) harvest vessel records or (2) histamine testing on every batch received of a representative sample of fish that shows less than 50 ppm histamine in all fish in the sample.
Harvest vessel records should include the following information: method of capture; date and time of landing; estimated time of death; 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 refer to Chapter 7 of FDA's Fish and Fishery Products Hazards & Controls Guidance: Third Edition for information on strategies to control histamine.
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 "SCOMBROTOXIC FISH" lists a monitoring procedure at the storage critical control point that is not adequate to control scombrotoxin formation. For example the critical limits states "Product to be completely covered with ice at [redacted] degrees or less" under the storage CCP but under the monitoring procedure of "WHAT" will be monitored your HACCP plan states that the cooler temperature will be monitored which is not consistent with monitoring the adequacy of ice. Please be advised that when monitoring the adequacy of ice, we recommend a frequency of twice daily. Alternatively, when monitoring cooler temperatures, in lieu of ice, we recommend use of a continuous monitoring instrument eg., recorder thermometer, time/temperature integrator, with a visual check of the instrument and the temperatures at least once per day.
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: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407)475-4763.
Emma R. Singleton
Director, Florida District