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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Conklin Enterprises, Inc. 19-Dec-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

Atlanta District Office

60 8th Street, N.E.

Atlanta, Georgia 30309

December 19, 2001

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Warning Letter

02-ATL-16

W. Phillip Conklin, President

Conklin Enterprises, Inc.

P.O. Box 972

Murrells Inlet, SC 29576

Dear Mr. Conklin:

On November 23, 24, and 27, 2001, an investigator from the Food and Drug Administration (FDA), Nancy E. Ford, conducted an inspection of your plant located at 3476 Highway 17 Business, Murrells Inlet, South Carolina. During that inspection, our investigator documented deviations from 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 deviations of concern areas follows:

1. Our review of your firm?s HACCP plan for histamine-producing fish reveals that it is

deficient and fails to meet requirements under 21 CFR 123.6(c) as follows:

  1. You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). However, your HACCP plan does not list a critical limit for the sensory examination at the "Receiving" (as a primary processor) critical control point (CCP) even though it lists sensory examination as one of the preventive measures used by your firm to address the histamine formation hazard.

In addition, your critical limit at the "Storage" CCP, i.e. "iced," is not adequate to

control the food safety hazard of histamine formation. It should describe what is an adequate amount of ice. For example, "Product completely covered in ice

throughout storage.".

b. You must have a HACCP plan that lists monitoring procedures for each critical

control point, to comply with 21 CFR 123.6(c)(4). However, your firm?s HACCP

plan does not list the monitoring procedure and frequency for the sensory

examination for decomposition at the "Receiving" CCP to control the histamine

formation hazard.

c. 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 at the "Storage" CCP is not adequate to control the

hazard of histamine formation. Specifically, re-icing product when the ice has

melted or is not sufficient to cover the fish may not be enough to prevent the

histamine formation hazard. The affected product must be evaluated by a trained

individual to determine its acceptability for distribution.

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.

2. You must implement the monitoring procedures listed in your HACCP plan, to comply

with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures of

checking the internal temperature of incoming histamine-producing fish, reviewing the

harvest vessel records, or performing a sensory examination for decomposition, for each

lot of histamine producing fish received. Moreover, there were no HACCP monitoring

records available for the "Receiving" critical control point for shipments of histamine fish

received between 7/18/01 and 11/21/01.

In addition, the presence of ice on histamine-producing fish received from other seafood

processors has not being documented.

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.

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 response 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,

Ballard H. Graham, Director

Atlanta District