Inspections, Compliance, Enforcement, and Criminal Investigations
Blue Water Connection Seafood Corp. 11/7/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
November 7, 2011
Blue Water Connection Seafood Corp.
2265 West 9th Avenue, Suite 2
Hialeah, FL 33010
Dear Mr. Gonzalez:
We inspected your seafood processing facility, located in Hialeah, FL from July 25, 2011 through August 1, 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 (21 CFR 123). 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 crab meat, fresh crab meat, swordfish, grouper, and tuna 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 and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with CFR 123.6(b). However, your firm does not have HACCP plans for the following products:
a. Canned pasteurized crab meat to control the food safety hazards of pathogen growth and toxin formation specifically Clostridium botulinum, and undeclared allergens.
b. Fresh crab meat to control the food safety hazards of pathogen growth and toxin formation and undeclared allergens.
c. Swordfish and grouper to control the food safety hazard of undeclared allergens.
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 follow the monitoring procedures at your receiving and storage Critical Control Points (CCPs) to control histamine formation listed in your HACCP plan for “Fresh Tuna, Mahi-Mahi, and Snapper”. For example:
a. You failed to implement your monitoring procedure at the storage CCP of “cooler temperature” and/or “presence of ice” since August 2009. Additionally, on July 25, 2011, you failed to sufficiently monitor the adequacy of ice surrounding product and the storage cooler’s temperature. Investigators observed your cooler’s temperature was 67.5 °F and the internal temperature of the tuna (without adequate ice) was 61.5 °F.
b. You failed to implement your monitoring procedures at the receiving CCP of “amount of ice at the time of receiving” and/or “internal temperature” since August 2009.
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, your corrective action plans for “fresh tuna, mahi-mahi, and snapper” at the storage CCP to control histamine formation is not adequate. Specifically, for your Product Storage CCP, your corrective action of “move product from malfunctioning cooler to another cooler”, and/or “add ice” do not correct the cause of the deviation. Additionally, you informed our investigators that you only have one cooler.
4. You must have a HACCP plan that lists the monitoring procedures and their frequency for each CCP, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “fresh tuna, mahi-mahi, and snapper” lists a monitoring procedure/frequency at the storage CCP that is not adequate to control histamine formation. Because you provide monitoring of the cooler temperature as an alternative method to monitoring the adequacy of ice, your monitoring frequency for cooler must be adequate. Your frequency of “twice a day” of the “cooler temperature” is not adequate. FDA currently recommends continuous monitoring of cooler temperatures with a daily review of the temperature recording chart to assure that critical limits have not been exceeded.
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.
Emma R. Singleton
Director, Florida District