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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Neukon Groves, Inc. 18-Aug-05

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

Public Health Service
Food and Drug Administration


555 Winderley PI., Ste. 200
Maitland, FL 32751



August 18, 2005

George A. Neukom III
Neukom Groves, Inc.
5409 Gall Blvd.
Zephyrhills, Florida 33542-3929

Dear Mr. Neukom:

We inspected your firm, located at 5409 Gall Blvd. on March 28-29, 2005, and found that you have serious deviations from the Juice HACCP regulation (21 CFR Part 120). These deviations cause your unpasteurized orange juice and grapefruit juice to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the Juice HACCP regulation through links in FDA's homepage at http://www.fda.gov.

The Juice HACCP regulation, which became effective on January 22, 2002, requires that you implement a preventive system of food safety controls known as Hazard Analysis Critical Control Point (HACCP). Juice HACCP involves: (1) identifying food safety hazards that, in the absence of controls, are reasonably likely to occur in your products; and (2) having controls at each "critical control point" in the processing operation to eliminate or minimize the likelihood that the identified hazards will occur. Prudent processors already take these kinds of measures. Juice HACCP provides a systematic way of identifying, implementing and documenting those measures that
demonstrate to FDA, to your customers, and to consumers, that you are routinely practicing food safety by design.

During our inspection, the investigator provided you with the form FDA 483, which presents his evaluation of your firm's performance regarding various aspects of the Juice HACCP requirements. The observations of concern to us are as follows:

1. You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 120.6(c) . However, your firm did not maintain sanitation control records for all eight (8) areas of sanitation, including:

(1) Safety of the water that comes into contact with food or food contact surfaces or is made into ice;
(2) Condition and cleanliness of food contact surfaces;
(3) Prevention of cross-contamination from insanitary objects to food, food packaging materials, and other food contact surfaces;
(4) Maintenance of hand-washing, hand-sanitizing, and toilet facilities;
(5) Protection of food, food packaging materials, and food contact surfaces from adulterants;
(6) Labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in microbiological contamination of food, food packaging materials, and food contact surfaces; and,
(8) Exclusion of pests from the facility.

2. You must have a written juice HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a Juice HACCP plan for unpasteurized orange juice and grapefruit juice (citrus juices that rely in whole or in part on surface treatment) to control the food safety hazard of pathogens . Furthermore, your firm does not have a written Hazard Analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards, for the unpasteurized orange juice and grapefruit juice.

We are in receipt of a handwritten letter from you to me dated April 4, 2005. Your response is inadequate because no supporting documentation was included substantiating your corrections to the form FDA 483 issued to you during the March, 2005, inspection of your facility.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

Please respond in writing within fifteen (15) working days 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 new juice HACCP plans, sanitation forms, critical control point monitoring records, or other useful information that would assist us in evaluating your corrections . If you are unable to complete all of the 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 facility operates in compliance with the Act and all regulations. 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 Food and Drug Administration, Attention : Diane J. Englund, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If ou have any questions regarding the implementation of the Juice HACCP regulation to your specific process, you may contact Ms. Englund at (407) 475-4741.



Emma R. Singleton

Director, Florida District