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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Winn Dixie Stores, Inc. 06-Dec-01


Food and Drug Administration

Atlanta District Office

60 8th Street, N.E.

Atlanta, Georgia 30309

December 6, 2001



Warning Letter


Al Rowland, President

Winn Dixie Stores, Inc.

Box B

Jacksonville, FL 32703-02997

Dear Mr. Rowland:

On July 30-31, 2001, an investigator from the Food and Drug Administration (FDA), Richard L. Garcia, conducted an inspection of your distribution center located at 2425 Nevada Boulevard, Charlotte, North 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. You must have a HACCP plan that lists the critical limits that with 21 CFR 123.6(c)(3). However, your HACCP plan

a. Does not list a critical limit at the "product receiving" must be met, to comply

critical control point to control the hazards of Pathogens from Harvest Area associated with molluscan shellfish. Chapter 4 (copy attached) of the Fish & Fisheries Products Hazards & Controls Guidance: Third Edition can provide guidance in determining the most appropriate method of control for the live molluscan shellfish you receive.

b. Lists a critical limit "Refrigerated storage maintained < 41 +/- 1.5?F," that is

inadequate to control the hazard of histamine formation in scombroid fish at the

"Refrigerated Storage" critical control point (CCP2). Critical limits must be

absolute values, not approximations. Your plan?s current critical limit potentially

allows unfrozen scombroid fish to be stored at temperatures as high as 42.4?F. Any exposure time above 40?F can contribute to conditions favorable for histamine

formation. FDA recommends 40 degrees F or less as an acceptable storage critical limit.

c. Lists a critical limit, "Product temperature <41 +/- 1.5?F at time of delivery," that is

inadequate to control the hazard of histamine formation in scombroid fish and

Pathogen Growth in Ready to Eat Seafood (Live Molluscan Shellfish) at the

"Product Receiving" critical control point (CCP1). FDA does not consider

individual internal temperatures an appropriate method of monitoring the conditions

that a lot has been exposed to during shipment. FDA recommends requiring and

reviewing transportation records showing that the fish were held at adequate

temperatures (40 degrees F or less in case of scombroid fish species) throughout shipment or making visual observations of the adequacy of ice or cooling media in a

representative number of containers.

Note: Your firm has chosen to use a HACCP plan for all incoming seafood products, the critical limits listed in your plan must apply to all products. For example, your listed target hazards are histamine formation and pathogen growth. Since histamine formation occurs at lower temperatures than most pathogen growth, your critical limits at Receiving and Storage must be set to control histamine (40 degrees F). If, during future investigations, we determine that you are receiving refrigerated vacuum packaged products, you would be required to set your critical limit for Receiving and Storage at a temperature that will control Clostridium botulinum, 38 degrees F. It is in your best interest to develop HACCP plans that target specific hazards. Fish that do not have those hazards would not be subject to the critical limits.

2. 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 plans at CCP1 (Receiving) and CCP2 (Storage) to control histamine are

not appropriate. You have listed that you will "Hold and evaluate seafood products."

"Evaluate" is too vague a term, and does not specify measures that are adequate to

determine the presence of histamine at objectionable concentrations. Histamine testing is

the only recommended and reliable method of determining the presence of histamine

concentrations of 50 ppm or higher. Products that have been exposed to abusive

temperatures for periods of time exceeding FDA safety guidelines must either be rejected

or tested for histamine.

Note: During our review of your records, we noted that the corrective action for CCP1

lists that warehouses will not accept products from suppliers that have not been verified

for the HACCP program. YOU do not appear to have procedures or records in place at the warehouse facilities for personnel to make that determination. FDA does not currently

consider it necessary for secondary processors to determine if U.S. processors or

importers have HACCP plans since all U.S. seafood processors and importers are

required to be operating in accordance with the U.S. Seafood HACCP regulation.

3. You must retain records at the warehouse facility for at least 1 year after the date they were prepared in the case of refrigerated products, to comply with 21 CFR 123.9(b)(l).

However, your firm?s monitoring records, which document the internal temperature of

incoming refrigerated seafood (including scombroid fish) for the period between 7/30/00

and 7/30/01, were not available for FDA review. Similarly, your firm?s sanitation control

records for that period of time were not available for FDA review. All of your HACCP

monitoring records must be available for review by FDA at reasonable times. This

includes the Corporate Supplier Records you have chosen to list in yow plan. Your

current system of forwarding the monitoring records to a corporate office for review by a

HACCP trained individual and maintaining listed monitoring records at that corporate

office precludes your warehouse horn meeting this requirement. In addition, when our

investigator requested the necessary records from your corporate office (when they were

unavailable at your warehouse), he was still unable to obtain them.

Note: You have chosen to use a standardized HACCP plan and standardized monitoring

records for eleven different warehouses and all seafood products. Records horn these

different warehouses are forwarded from each warehouse to a single individual at your

corporate office for review. The documents do not contain identifying addresses on the

individual monitoring records to designate their point of origin. The North Carolina

Department of Agriculture commented on the absence of identifying addresses or

locations on the HACCP plan and records in their letter dated March 26, 1999. A

response from your representative stated that you felt placing the warehouse addresses on

a single separate page of the HACCP plan was sufficient and that no changes to your

HACCP plan were necessary. lifter further evaluation of your record keeping and

verification procedures, FDA recommends that you review this decision. 21 CFR

123.9(a)(l) requires processors to include their name and location on all records.

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 horn 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

Adrninistration, 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.


Ballard H. Graham, Director

Atlanta District