Inspections, Compliance, Enforcement, and Criminal Investigations
Neukom Groves, Inc. 5/17/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
May 17, 2012
Mr. George A. Neukom
Neukom Groves, Inc.
5409 Gall Blvd.
Zephyrhills, FL 33542
Dear Mr. Neukom,
We inspected your juice processing facility, located at S409 Gall Blvd, Zephyrhills, FL from 2/6/2012 to 2/24/2012, and found that you have serious deviations from the FDA's juice processing regulation (21 CFR Part 120). These deviations cause your Orange, Grapefruit and Tangerine 100% juice products to be in violation of 21 CFR Part 120, as promulgated under the authority of Section 361 of the Public Health Service Act (PHS Act). You can find the PHS Act and the juice HACCP regulation through links in FDA's home page at www.fda.gov.
The observations of concern to us are as follows:
1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a S log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism, to comply with 21 CFR 120.24(a).
However, your HACCP "Plan Summary'' fails to list control measures that will consistently achieve a 5-log reduction in the pertinent microorganism. This 5-log reduction and final product packaging must be accomplished in your facility through treatments applied directly to the juice to comply with 21 CFR 120.24(b) and (c).
The combination of processing methods for which you provided your firm's "Fresh Squeezed Juice Log Reduction Chart" provides a list of processes and associated microbial load reductions with study references for each method. However, you were not able to provide any assurance that you are performing the same steps that were used in these studies or that the combination of methods you use results in at least a 5-log reduction of the most pertinent organism.
2. Your HACCP plan must, at a minimum, list the procedures and frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits, to comply with 21 CFR 120.8(b)(4).
However, your HACCP plan for 100% fresh squeezed citrus juices including orange and grapefruit juice lists the critical limit of minimum 200 ppm of acid sanitizer including (b)(4) seconds brush time and (b)(4) seconds of rinse time at the CCP of "acid brush wash and rinse". Your HACCP plan states that this Critical limit will be monitored by testing the sanitizer using a test kit at the beginning of the operation by an employee of the firm. This procedure does not include monitoring for the sanitizer contact time and water rinse time. In addition our records do not include monitoring for the (b)(4) second sanitizer contact time and (b)(4) second water rinse time, nor do you monitor the sanitizer contact time or the (b)(4) water rinse time.
3. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with the conditions and practices specified in the CGMP regulation in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, our inspection showed that your firm did not monitor the exclusion of pests as evidenced by:
• Numerous live fruit flies were observed on the metal conveyor ramp directing fruit to the fruit sanitizing step. The jagged edges and underside of this ramp had a build up of food particles and debris from oranges that were cut and bruised along this surface. Fruit flies were attracted to the debris adhering to these surfaces.
• Live fruit flies and other insects such as wasps were found at the rear of the facility where an accumulation of citrus fruit peels and debris is conveyed by an auger into a dumpster following the extraction process. A large pool of citrus juice also accumulates underneath the dumpster which sits in a depression in the ground. A bay door leading directly to this area is left ajar during processing.
• A lizard was observed on a cart which is used to transport bins of sanitized oranges into the extraction room.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the PHS Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the Public Health Service Act and all applicable regulations.
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, an injunction.
Please respond in writing within fifteen ( 15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these deviations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, 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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31 (a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Carla Norris Compliance Officer, 555 Winderley Place, Suite 200, Maitland FL, 32751. If you have questions regarding any issue in this letter, please contact Carla Norris at 407-475-4730.
Emma R. Singleton
Director, Florida District