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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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James Styron Fish Company 27-May-04

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

Public Health Service
Food and Drug Administration


Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309

May 27, 2004



James F. Styron, Owner
James Styron Fish Company
US 70, P.O. Box 56
Davis, NC 28524

Warning Letter

Dear Mr. Styron:

On April 21 - 22, 2004, FDA conducted an inspection of your seafood processing facility located at Davis, North Carolina. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations. Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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 fresh, scombrotoxin forming fish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulations through links in FDA's home page at www.fda.gov.

The deviations of concern are at follows:

1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety, hazard." However, your firm's HACCP plan for fresh, scombrotoxin forming fish lists a critical limit of "less than [redacted] hours from death to icing" at the "Receiving" critical control point. This critical limit is not adequate to control the histamine formation hazard. We have enclosed a copy of Chapter 7 of the Fish & Fisheries Products Hazards & Controls Guidances (third edition), which deals with the control of the histamine formation hazard in certain species of fish. We trust you will find this guidance useful when developing an adequate critical limit for your operation. Remember that the monitoring procedures for the "Receiving" critical control point will also need to be modified so they can properly address the new critical limit(s).

2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the "Receiving" critical control point to control the histamine formation hazard listed in your HACCP plan for fresh, scombrotoxin forming fish. You failed to provide our investigator with any records that document any monitoring observations generated by your firm upon receipt/examination of these type of fish.

3. You must have a HACCP plan that at a minimum lists monitoring procedures for each critical control point; to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for fresh, scombrotoxin forming fish lists a monitoring frequency at the "Cooler" critical control point that is not adequate to control the histamine formation hazard. Specifically; your monitoring frequency of "one or more daily" should be changed to "twice or more daily." We acknowledge that you are indeed monitoring the cooler temperature twice a day.

4. Since you chose to include corrective actions 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 flesh, scombrotoxin forming fish at the "Cooler" critical control point is not appropriate to control the histamine formation hazard. Specifically, it lacks a provision for segregation and evaluation of the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation from the critical limit.

We may take further action if you do not promptly correct these violations. For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should 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.



Mary H. Woleske, Director
Atlanta District