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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ambassador Meat Distributors Inc 21-Dec-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Kansas City District
Southwest Region
11630 West 80 Street
Lenexa, Kansas 66214-3340

Telephone: (913) 752-2100


December 21, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref. KAN 2008-01

Mr. John F. Scavuzzo, Owner and President
Ambassador Meat Distributors Inc.
305 Chancery Circle
Naples, FL 34110

Dear Mr. Scavuzzo:

We inspected your seafood processing facility, located at 2856 Guinotte Ave in Kansas City, Missouri on 8/29/2007 - 8/31/2007. 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 refrigerated reduced oxygen packaged Mahi Mahi Onion and Bell Pepper Kabobs 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; 3rd Edition through links in FDA's home page at www.fda.gov.

Your significant violation is as follows:

You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for refrigerated reduced oxygen packaged Mahi Mahi Onion and Bell Pepper Kabobs to control the food safety hazards of Clostridium botulinum growth and potential toxin formation and histamine development.

For additional information concerning the hazard of Clostridium botulinum, please refer to Chapter 13 of FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide). For more information on the hazard of histamine in scombroid species of fish, please refer to Chapter 7 of the Hazard Guide. You can access the Hazard Guide on our web site at: http://www.cfsan.fda.gov/~comm/haccp4.html

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 facility 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: Amy E. Devine, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Rich Pendleton, Compliance Director, at (913) 752-2101.

Sincerely,

/S/

John W. Thorsky
District Director
Kansas City District

Cc: Mr. Thor Johnson, R&D Manager
Ambassador Meat Distributors Inc.
2856 Guinotte Ave
Kansas City, MO 64120-2002