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Universal Pasteurization LLC MARCS-CMS 455150 —

Universal Pasteurization LLC

United States

Issuing Office:
Dallas District Office

United States


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

Public Health Service
Food and Drug Administration
Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204 


August 24, 2015
Jeffrey L. Barnard, President
Universal Pasteurization, LLC
1601 Pioneer Blvd
Lincoln, Nebraska 68502
Dear Mr. Barnard:
On January 20 and 22, 2015, February 5, 2015, and March 3, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 777 Freeport Pkwy, Suite 130, Coppell, Texas, where you conduct cold high pressure processing (HPP) of juice products. We found you have serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation - Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) 342(a)(4)]. Therefore, the (b)(4) 100% juice blend products processed for customers by your firm are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the Juice HACCP regulation, and the Juice HACCP Hazards and Control Guidance through links on FDA's Internet home page at http://www.fda.gov.
We received and reviewed your written response to the form FDA 483, which was received by FDA on April 14, 2015. Your response indicated your firm would reassess and revise, as needed, your firm's HACCP Plan and Hazard Analysis to address the listed concerns on the form FDA 483. Your response did not include specific corrective actions that your firm would implement to address any of the deficiencies, or a timeframe for implementing any corrections. Therefore, we cannot determine the adequacy of your response.
Significant violations found during our inspection include the following:
1.    Your hazard analysis and HACCP plan must identify and address the food hazards that are reasonably likely to occur, to comply with 21 CFR 120.7(a) and 120.8(b)(1). A food hazard is defined in 21 CFR 120.3(g) as "any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control." However, your hazard analysis entitled "Hazard Analysis - Juice" and your HACCP plan entitled "Pasteurized Juice Blends" do not include the food hazard of: Pathogen growth and toxin formation including Clostridium botulinum, which is reasonably likely to occur in low-acid juice products. Your firm receives unpasteurized refrigerated 100% juice blend products with unknown pH levels, to include blends with carrot juice, in hermetically sealed final containers for HPP processing. Low acid juices, such as carrot juice, that are distributed under refrigeration may pose hazards associated with spore forming pathogens, specifically, toxins of Clostridium botulinum. You did not evaluate the potential hazard of Clostridium botulinum in your hazard analysis.
You must have a hazard analysis and a HACCP plan that is specific to each type of juice you process, to comply with 21 CFR 120.7(a) and 21 CFR 120.8(a)(2). However, your firm has one hazard analysis and one HACCP plan for all of the unpasteurized refrigerated 100% juice blend products processed by your firm. The same HACCP plan may be used for similar juices provided the food hazards, critical control points, and critical limits procedures to monitor each of the critical control points controls are identical, however, you have not demonstrated that the applicable hazards and controls are identical for each of the juice products that you process. Since you do not have documentation of the pH levels of the juices you receive for processing, it is possible that some are low-acid, while others are acid juices. Therefore, they likely have different hazards and controls.
2.    You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of pertinent microorganisms, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). However, your firm does not have validated control measures in your HACCP plan to ensure that your Critical Control Point CCP1 , High Pressure Processing, consistently achieves a 5-log reduction of the pertinent pathogens for any of the unpasteurized refrigerated 100% juice products processed on your equipment.
3.    Because you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 120.10. However, your HACCP plan has a corrective action "reprocessing to the set specifications" at CCP 1, High Pressure Processing, that is not complete because it does not specifically address the cause of the deviation, as required by 21 CFR 120.10(a)(2).
This letter is not intended to include a comprehensive list of violations at your facility. It is your responsibility to ensure your facility operates in full compliance with the Act, the Juice HACCP regulation, and all applicable federal regulations.
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to correct these violations may result in regulatory action without further notice, including seizure or injunction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover 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 there-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.
You should notify this office in writing, within fifteen (15) working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as copies of your Juice HACCP Hazard Analysis, Juice HACCP plans, process controls for 5-log reduction of pertinent microorganisms, or other useful information which would assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Please address your reply to Rose M. Ashley, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Ashley at (210) 308-1407.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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