Inspections, Compliance, Enforcement, and Criminal Investigations
Advantage Foods, LLC 9/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
September 6, 2011
Advantage Foods, LLC
11788 66th Street, Suite G
Largo, FL 33773
Dear Mr. Dephoure:
We inspected your seafood processing and importer establishment, located in Largo, FL from April 26, 2011 through May 9, 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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)].
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, [21 U.S.C. §342(a)(4)].
Accordingly, your canned pasteurized crab meat, mahi-mahi, grouper, snapper, amberjack, stone crab claws, and fresh crab meat 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 monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However,
a. Your firm’s HACCP plan for amberjack, bluefish, escolar, mackerel, mahi-mahi, tuna, wahoo, and swordfish lists monitoring procedure(s)/frequency at the receiving and storage CCPs that are not adequate to control histamine formation. Specifically,
i. the receiving CCP lists the monitoring procedure of “temp of fish when received from boats or trucks” which does not ensure compliance with the critical limit of “all fish must be kept below 40° F at all times”.
ii. The storage CCP lists the monitoring procedure of “temp of fish & filets throughout processing and up to time of shipment”. The frequency of this monitoring procedure appears to be “every”. This monitoring procedure/frequency is not clear and does not ensure compliance with the critical limit of “40 °F or below must be”.
b. Your firm’s HACCP plan for ready to eat pasteurized crab meat lists a monitoring procedure(s)/frequency at the receiving CCP that is not adequate to control Clostridium botulinum. Specifically, the receiving CCP lists a monitoring procedure of “temp during shipment” taken “once upon receiving” which does not ensure compliance with the critical limit of having the “shipper verify product temp has been below 40° throughout shipment, check and record of truck upon delivery”.
2. You must implement the monitoring procedures and frequencies 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 “twice daily” “visually” observing “iced crabmeat” at the storage CCP to control Clostridium botulinum. Specifically, the investigator observed pasteurized crabmeat being stored without ice in your cooler.
3. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for at least the following products:
a. Fresh grouper that you imported from (b)(4) on 04/26/2011 (U.S. Customs entry number D97-0586567-0/3/1 and D97-0586567-0/4/1) and 04/28/2011 (U.S. Customs entry number D97-0586895-5/1/1 and D97-0586895-5/4/1).
b. Fresh snapper that you imported from (b)(4) on 04/26/2011 (U.S. Customs entry number D97-0586567-0/1/1 and D97-0586567-0/2/1).
c. Fresh amberjack that you imported from (b)(4) on 04/18/2011 (U.S. Customs entry number D97-0585453-4/1/1).
d. Fresh stone crab claws that you imported from (b)(4) on 02/08/2011 (U.S. Customs entry number D97-0575324-9/1/1).
e. Fresh crab meat that you imported from (b)(4) on 12/27/2010 (U.S. Customs entry number D97-0568946-8/2/1).
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 action plan for amberjack, bluefish, escolar, mackerel, mahi-mahi, tuna, wahoo, and swordfish at the storage CCP to control histamine formation is not appropriate. Specifically, your corrective action of “chill” does not correct the cause of the deviation.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act [21 U.S.C. §381(a)], including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
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 importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Andrea Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Ms. Norwood at (407) 475-4724.
Elizabeth W. Ormond
Acting Director, Florida District