| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human ServicesAugust 13, 2010
VIA UPS OVERNIGHT
WARNING LETTER CIN-10-116948-21
Mary Ann Bonds, President
Juice Pac, Inc.
5796 Nashville Road
Bowling Green, KY 42102-1172
Dear Ms. Bonds:
We inspected your juice processing facility, located at the above address, on May 4, 5 and 6, 2010. We found that you are manufacturing 100% juice concentrate products subject to the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). We found that you have serious violations from the HACCP regulations. 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 Part 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 U.S.C. § 342(a)(4). Accordingly, your juice concentrates 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 Controls Guidance through links in FDA's home page at www.fda.gov.
The significant deviations were as follows:
1. For your Drink Bases which are 100% Juice with other added ingredients, you must perform a 5-log reduction, in the pertinent microorganism(s), to comply with 21 CFR 120.24(a). 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). However, your firm fails to perform a 5-log reduction in Drink Bases which are 100% Juice with other added ingredients for the pathogens.
2. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 120.8(b)(2). However, your firm's HACCP plan for Drink Bases which are 100% Juice with other added ingredients does not list the critical control point of pasteurization for controlling the food safety hazard of pathogens.
3. 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 of the condition of cleanliness of food contact surfaces, prevention of cross contamination,maintenance of hand washing and toilets, protection of food and packaging from adulteration, proper labeling, storage, use of toxic compounds, and control of employee health.
We have reviewed your letters dated May 12, 2010 and May 17, 2010 in which you responded to the FDA-483 Observations that was issued at the completion of the inspection. Additionally, you posed the following question in your May 17, 2010 letter:
Does Juice Pac meet the 5-log pathogen reduction performance standard if it does all of the following:
1) Documents that the juice concentrate ingredients have received a 5-log pathogen reduction process.
2) Designates as a critical control point in its HACCP plan the receiving of the juice concentrate ingredients in multi-use containers with single-use liners (totes with liners or drums with liners) and multi-use containers without liners (tankers).
3) Documents that its drink base is supplied to its customers with the recommendation that the finished drinks must receive a 5-log pathogen reduction process.
Your firm does not meet the 5-log reduction if those conditions are met. In order to meet the 5-log pathogen reduction, you must apply the 5-log pathogen reduction. For your information, we are enclosing a copy of an FDA Guidance for Industry that may be helpful to your firm, entitled "Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices." This guidance is also available on FDA's website at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm0
72621.htm. That letter describes the circumstances under which FDA has agreed to consider the exercise of enforcement discretion with respect to the "single facility" requirement as applied to producers and users of high °Brix juice concentrate. According to the letter, FDA is considering the exercise of its discretion where the following three conditions are satisfied: (1) the producer and the user establish appropriate prerequisite and Sanitation Standard Operating Procedures (SSOPs) for the transport of high °Brix juice concentrate; (2) the producer and user designate as a critical control point (CCP) in their respective HACCP plans the transport of high °Brix concentrate from the production facility to a second facility for formulation and final packaging of concentrates; and (3) the producer and user establish control measures to prevent, reduce, or eliminate the risk of recontamination of the concentrate during transport. The Agency expects that any producer of high °Brix juice concentrate whose HACCP plan does not designate such transport as a CCP and establish appropriate control measures will comply with the "single facility" requirement on the effective date of the final rule.
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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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 corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter please contact Mr. Rabe at 513-679-2700 ext. 163.
Sincerely,
/s/
Teresa C. Thompson
District Director
Cincinnati District
Enclosure
Guidance for Industry: Guidance on Bulk Transpoli of Juice Concentrates and Certain Shelf-Stable Juices; Final Guidance, April 24, 2003
Cc: (VIA UPS) Jeffery M. Bonds, Vice President
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