Inspections, Compliance, Enforcement, and Criminal Investigations
Haag & Sons Seafood 24-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309
October 24, 2001
VIA FEDERAL EXPRESS
Jon Haag, Owner
Haag & Sons Seafood
1117 Yaupon Drive
Oak Island, NC 28465
Dear Mr. Haag:
On June 11 & 12, 2001, Nancy E. Ford, an investigator with the Food and Drug Administration (FDA) conducted an inspection of your plant located at Oak Island, North Carolina. During that inspection, our investigator documented deviations horn the Seafood HACCP regulations (21 CFR Part 123). These deviations cause your fresh histamine-producing fish to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov.
The HACCP deviation of concern is as follows:
You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for flesh histamine-producing fish to control the food safety hazard of histamine formation. We suggest that you refer to Chapter 7 of the Fish & Fisheries Products Hazards & Controls Guidance, third edition (copy enclosed), for guidance in establishing critical limits and monitoring procedures for controlling the histamine hazard in the fish you process.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your product(s) and/or enjoin your firm horn operating.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as copies of HACCP plans, and HACCP monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (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 Carlos A. Bonnin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mr. Bonnin at 404-253-1277.Sincerely,
Barbara G. Wood for
Ballard H. Graham, Director