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Public Health Service |
New Orleans District Telephone: (615) 366-7801 |
June 19, 2008
WARNING LETTER NO. 2008-NOL-18
FEDERAL EXPRESS
DELIVERY SIGNATURE REQUIRED
Shellie D. Schwartz, President
Captain Jackie's Seafood, Inc.
9675 Dauphin Island Parkway
Theodore, Alabama 36582-7231
Dear Ms. Schwartz:
During an inspection of your seafood processing facility, located at 9675 Dauphin Island Parkway, Theodore, Alabama on March 26 -- 28, and April 2, 2008, an investigator from the U.S.
Food and Drug Administration (FDA) found 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 (CGMP) regulation for foods, 21
CFR 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 to comply 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 United States Code, Section 342(a)(4)]. Accordingly, your histamine-forming fish (Spanish
Mackerel, Bluefish, Amberjack, Bonito, Gemfish, Jack Crevalle, Blue Runner, Rainbow Runner,
King Mackerel, Almaco Jack, and Wahoo) are adulterated because 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 Internet home page at www.fda.gov.
Violations requiring your immediate attention are as follows:
1 . You must implement the record keeping system you listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(7). Your firm did not record monitoring observations at the receiving critical control point to control histamine formation, as listed in your HACCP plan for histamine-forming fish Specifically, you failed to record monitoring observations during the receipt of histamine-forming fish on 60 occasions between June and December 2007. We expect you will monitor all of your incoming histamine-forming fish at receipt, including Almaco Jack, even if the histamine-forming fish are not the predominant species in a particular lot or catch.
We may take further regulatory action if you do not promptly correct these violations For instance, we may seize your product(s) and/or enjoin your firm from operating.
The FDA requests a written response 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 monitoring records, or other useful information which 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 your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 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: Mark W. Rivero, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 219-8818, Extension 103.
Sincerely,
/s/
H. Tyler Thornbug
District Director
New Orleans District
Enclosure: Form FDA 483
Department
of Health and Human Services