| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-21
March 25, 2011
Howard M. Bubis
Owner
Day Boat Seafood, LLC
1335 Old Dixie Highway, Unit 17
Lake Park, FL 33403
Dear Mr. Bubis:
We inspected your seafood processing facility, located at 1335 Old Dixie Highway, Unit 17, Lake Park, Florida 33403 on December 7 and 12, 2010 and January 12-13 and 19, 2011. 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 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 Barracuda, Grouper, Mackerel, Mahi Mahi, Triggerfish and Wahoo are adulterated, in that they 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 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 revised HACCP plan for “SCOMBROID-TOXIN FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS” lists a critical limit, “sensory evaluation of each shipment and harvest vessel trip ticket report”, at “Receiving” critical control point that is not adequate to control the hazard of histamine formation. Specifically, the critical limit does not provide an actual value associated with the receipt of fish rather than “1-12 hours from haulback”; FDA recommends temperature of below 40ËšF.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement the monitoring procedures as follows:
• Your firm did not follow the monitoring procedure of “Declaration from captain or dealer/Each Load” at “Receiving” critical control point to control Ciguatera poison listed in your HACCP plan for CIGUATERA POISON FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS. Specifically, your firm failed to obtain a declaration signature of harvest area on 24 trip tickets dated from August 8, 2010 through September 10, 2010.
• Your firm did not follow the monitoring procedure of “Random Probe & w/Calibrated Thermometer on weight sheet for Each Load” at “Receiving” critical control point to control Histamine Formation listed in your HACCP plan for SCOMBROID-TOXIN FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS. Specifically, your firm did not record internal fish temperatures on 41 receiving documents from August 9, 2010 through September 13, 2010.
• Your firm did not follow the monitoring procedure of “Visual & Record twice daily” at the “Storage” critical control point to control Histamine Formation listed in your HACCP plan for SCOMBROID-TOXIN FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS. Specifically, your firm failed to record cooler temperatures on 28 Daily Sanitation Logs from the time period of August 2, 2010 through October 19, 2010.
In addition the number of fish (3) evaluated for sensory evaluation is inadequate. There should be a representative number to the number of fish in the lot. For example, when receiving 10 tons or more of fish, a minimum of 1 fish per ton should be measured. When receiving less than 10 tons of fish at least one fish per 1000 pounds should be measured. A minimum of 12 fish should be measured unless there are fewer than 12 fish in the lot, in which case you should measure all the fish.
In addition, the records do not contain a dedicated area for documentation of the sensory evaluation. Currently, your firm is calling for sensory testing to be documented on the Trip ticket; however, there is no place for the evaluation to be documented.
3. 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 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 SCOMBROID-TOXIN FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS lists a critical limit “harvest vessels trip ticket report”, at the “RECEIVING” critical control point that is not adequate to control histamine formation. Specifically, the listed critical limit does not address cooling and holding conditions aboard the vessels necessary to control histamine development.
4. 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 actions are not appropriate as follows:
• Your corrective action plan for CIGUATERA POISON FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS at the “RECEIVING” critical control point to control Ciguatera poison is not appropriate. Specifically, your firm did not list discontinuing the use of the supplier as a corrective action.
• Your corrective action plan for SCOMBROID-TOXIN FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS at the “RECEIVING” critical control point to control Histamine formation is not appropriate. Specifically, the corrective action plan does not include the step of performing sensory exams on all fish. Also, the disposition of individual fish with decomposition (e.g., destruction or diversion to non-food use) is not listed. Additionally, your firm did not list discontinuing the use of the supplier as a corrective action.
• Your corrective action plan for SCOMBROID-TOXIN FORMING SPECIES FOR PRIMARY AND SECONDARY RECEIVERS at the “STORAGE” critical control point to control Histamine formation is not appropriate. Specifically, the plan does not list identification of the cause and subsequent repair of the cooler.
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 U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.
Sincerely,
/s/
Emma Singleton
Director, Florida District
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