| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-26
April 28, 2011
Mr. Mac Chen
Owner
Captain’s Fine Foods, LLC
1601 N. 50th Street
Tampa, FL 33619
Dear Mac Chen:
We inspected your seafood processing facility, located at 1601 N. 50th Street on February 23 – March 2, 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 ready to eat pasteurized crabmeat and King (Spanish) Mackerel 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 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 follow the monitoring procedure of “Continuous Recording Thermometer” at “Crab Storage” critical control point to control Clostridium botulinum toxin type A, and proteolytic type B and F listed in your HACCP plan for Pasteurized Refrigerated Crab.
We acknowledge that in your written response you state that you have installed a continuous monitoring system; however you did not provide any documentation to verify the installation and proper use of the system.
2. 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 Pasteurized Refrigerated Crab and King Mackerel (Scomberomorus cavalla) at the “Crab Receiving” and “Receiving” critical control point to control Clostridium botulinum toxin type A, and proteolytic type B and F and Scombrotoxin formation is not appropriate. Specifically observed were the following:
o Your HACCP plan for “Pasteurized Refrigerated Crab” at the critical control point for “Crab Receiving” lists the corrective action procedures of “hold and evaluate product”. These corrective action procedures do not assure that the cause of the deviation was corrected or sufficiently describe the method of evaluation.
o Your HACCP plan for “King Mackerel” (Scomberomorus cavalla) at the critical control point for “Receiving” lists the corrective action procedure “reject lot”. This corrective action procedure does not assure that the cause of the deviation was corrected. FDA recommends discontinuing use of the supplier or transporter until corrections have been made.
We acknowledge in your response you state that the deviation occurs at receiving and therefore it is the primary processors responsibility and not yours. However, for hazards such as scombrotoxin formation and pathogen growth and potential toxin formation, FDA has placed the burden of assuring the safety of seafood that has been transported from one processor to a subsequent processor on the processor who receives the product. That firm has been determined to be the most responsible for receiving safe products, requiring assurances of safe transport conditions from transporters, and of rejecting product or taking corrective actions when conditions have been potentially unsafe. It is your firm’s responsibility to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation from your listed critical limits and that the cause of the critical limit deviation is corrected.
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: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/s/
Emma R. Singleton
Director, Florida District
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