| Public Health Service Food and Drug Administration |
Chicago District |
Department of Health and Human ServicesFebruary 4, 2011
WARNING LETTER
CHI-04-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Phillip L. Scott
President
Juice Tyme, Inc.
4401 South Oakley Avenue
Chicago, Illinois 60609
Dear Mr. Scott:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility, located at 4401 South Oakley Avenue, Chicago, Illinois, on July 20, 2010 through September 30, 2010. The inspection revealed that you are manufacturing juices and you have serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 & 110).
In accordance with 21 CFR 120.9, failure of a processor of juice or juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice or 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 Premium Orange 4 + 1 with Pulp juice product is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 juice HACCP violations documented during this inspection include the following:
1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5 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 for “Premium Orange 4 + 1 with Pulp” fails to list measures that will 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).
According to your October 13, 2010 response, your firm indicates that Juice Tyme, Inc. is currently in the advance stages of installing a pasteurization system that would perform the necessary 5-log reduction of microorganisms of this product. However, as mentioned above, the “Premium Orange 4 + 1 with Pulp” you currently market and manufacture requires a 5-log reduction and the study you provided to FDA does not ensure the safety of the “Premium Orange 4 + 1 with Pulp”. Your documentation failed to identify the critical factors that result in a 5-log reduction and failed to document that the process you are using is identical to the conditions in the study provided.
2. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 120.6(b). However, your firm did not monitor condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration, and exclusion of pests with sufficient frequency, as evidenced by:
• On 8/3/10, four fly-like insects were observed flying in the processing and packaging areas of your firm as your were manufacturing 100% Premium Orange w/ Pulp and Passion Orange Guava 25% 4+1.
• On 7/20/10, one fly-like insect was observed in the packaging area of your firm while you were packaging 100% Premium Orange w/ Pulp.
• On 8/3/10, lemon concentrate was observed being filled (b)(4) into final packaging. The (b)(4) was observed damaged and sealed with tape.
• On 8/18/10, two fly-like insects were observed in the blending room where Premium Orange 4+1 100%, code (b)(4) was being manufactured.
• On 8/18/10 a dead fly-like insect was observed within a (b)(4) of lemon juice concentrate directly on the interior plastic liner.
In addition, the inspection of your facility also revealed that you are a manufacturer of acidified food products. As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulation was issued pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114. In addition, based on certain criteria in Part 114, acidified foods may be adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they have been manufactured under conditions such that they are unfit for food, or within the meaning of Section 402(a)(4) (21 U.S.C. § 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located through FDA’s homepage at http://www.fda.gov.
During the inspection, our investigators documented deviations from the Act and the above-mentioned regulations relating to the processing of the following acidified foods: Thickened Water Nectar, Thickened Water Lemon, and Thickened Water Honey. These deviations cause your acidified food products to be adulterated and in violation of Section 402(a)(4) of the Act, in that your Thickened Waters have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations on the Internet through links on the FDA’s home page at http://www.fda.gov.
The significant deviations we found at your acidified food processing facility are as follows:
1. As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm has failed to file a scheduled process for each of the thickened water products you manufacture.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm.
In addition, your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a Form FDA 2541 with the FDA, as required by 21 CFR 108.25(c)(1).
For additional information on the types of products FDA considers to be acidified foods (including thickened water beverages), please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm.
2. Your firm failed to establish scheduled processes of your acidified foods by using a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods as required by 21 CFR 114.83. Specifically, your firm does not have scheduled processes established by an acidified foods expert for the Thickened Water Nectar, Thickened Water Lemon, and Thickened Water Honey acidified food products.
3. You firm failed to thermally process your acidified foods to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user as required by 21 CFR 114.80(a)(1). Specifically, your firm’s Thickened Water Nectar, Thickened Water Lemon, and Thickened Water Honey products do not receive a thermal process.
4. Your firm failed to exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, your firm does not monitor or record the finished equilibrium pH of any of the acidified thickened water products you manufacture to ensure that the finished equilibrium pH does not exceed 4.6.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or rosemary.sexton@fda.hhs.gov.
Sincerely,
Scott MacIntire
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