Inspections, Compliance, Enforcement, and Criminal Investigations
Kingston-Miami Trading Company 20-Apr-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
April 20, 2006
Patrick A. Cha-Fong, President
Kingston-Miami Trading Company
1465 NW 21st Terrace
Miami, Florida 33142
Dear Mr. Cha-Fong:
We inspected your seafood processing and importer establishment, located at 1465 NW 21st Terrace, Miami, Florida 33142 on December 15, 16, 21 & 22, 2005. We found thatyou 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), 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).
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 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 refrigerated salted (and/or pickled/cured) vacuum packaged scrombroid species (Mackerel/Herring) 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 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 canned mackerel in tomato sauce manufactured by [redacted]
2. 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 refrigerated salted (and/or pickled/cured) vacuum packaged scombroid .species (Mackerel/Herring) lists monitoring procedures at the receiving and storage critical control points that are not adequate to control histamine formation and Clostridium botulinum growth and toxin formation.
Specifically, your HACCP plan states that at receiving you will take two temperature readings for each shipment and that this data will be recorded on the receiving log and at storage you will monitor cooler temperature once per day. The FDA does not consider intermittent temperature checks during receiving and storage periods to be an adequate method of assuring that histamine-forming fish and refrigerated vacuum packaged fish are held at safe temperatures. Because your products are not shipped to your facility in cooling media, FDA suggests that you monitor product temperatures for those products transported less than 4 hours using a calibrated thermometer. For products in transit for extended time periods (e.g. longer than 4 hours), FDA suggests the use of a method of continuous temperature monitoring such as a time/temperature data logger, recorder thermometer or a high temperature alarm with 24 hour monitoring capabilities that monitors the ambient temperature of the truck cargo area. This monitoring frequency should be continuous by the instrument itself with a visual check of the instrument at least once per day. Please be certain that you also include all appropriate monitoring records to ensure that temperatures are maintained and that you take appropriate corrective actions when necessary.
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 fifleen (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 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: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Mr. Schroeder at (407) 475-4763.
Director, Florida District
Emma R. Singleton