Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
August 5, 2014
Lisa M. Reed; Owner
Garden of Flavor, LLC
7501 Carnegie Avenue
Cleveland, OH 44103
Dear Ms. Reed:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 7501 Carnegie Avenue, Cleveland, OH on January 14-15 and February 4, 7, 2014. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation [21, Code of Federal Regulations (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 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food Drug and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Accordingly, your 100% juice blends “Lemon Pepp”, “Goji Pineapple”, “Appleade”, “Twisted Roots”, “Mean Green” and “Cucumber Fresh” 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, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
We received your response dated February 21, 2014, concerning our investigator’s observations noted on the February 7, 2014, Form FDA-483, Inspectional Observations (FDA-483) issued to you at the close of the inspection. Your response is addressed below in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. 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 evidence that the (b)(4) performed on your juice products by (b)(4) achieves a 5-log reduction of the most pertinent organism for each of your 100% juice products (“Lemon Pepp”, “Goji Pineapple”, “Appleade”, “Twisted Roots”, “Mean Green” and “Cucumber Fresh”.) Your firm’s validation studies appear to be inadequate in that the testing was conducted on a “cocktail” of microorganisms rather than a “pertinent microorganism” identified for each type of juice (i.e. the pathogen most resistant to the (b)(4). Although the “cocktail” may have included a resistant microorganism, there is no indication that this was the microorganism measured in the study. Additionally, the known effects of Brix and acidity of each product were not specifically addressed. The study also did not address whether the (b)(4) was effective for the shelf life of the product under moderate abuse conditions. Therefore, we cannot verify the applicability of the two validation studies to all of the juices manufactured by your firm.
2. You must have a HACCP plan that is specific to each type of juice processed by the processor, to comply with 21 CFR 120.8(a)(2). However, your firm has one HACCP plan for all of your juice products and you do not list the hazards in relation to each specific type of 100% juice blend processed by your firm: “Lemon Pepp”, “Goji Pineapple”, “Appleade”, “Twisted Roots”, “Mean Green” and “Cucumber Fresh”. The same HACCP plan may be used for similar juices provided the hazards and controls are identical; however, because your validation study did not demonstrate that the applicable hazards and controls are identical for each juice, separate juice HACCP plans are necessary.
3. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However your firm did not monitor: the safety of water that comes into contact with food or food contact surfaces; the condition and cleanliness of food contact surfaces; the prevention of cross-contamination from insanitary objects; the maintenance of hand washing, hand sanitation and toilet facilities; the protection of food, food packaging materials and food contact surfaces from adulteration with contaminants; the proper labeling storage and use of toxic compounds; and the control of employee health conditions. Your firm’s written response is not adequate because it does not specify a monitoring frequency for any of the above listed items. In addition, you also did not provide any copies of monitoring records that demonstrate your firm’s implementation of your new monitoring and recording Sanitation Standard Operating Procedures (SSOP).
4. 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 corrective action plan for all products at; CCP 1, Straining; CCP 2, Testing juice pH; and CCP 3, Shipping in refrigerated truck for (b)(4) are not appropriate because they do not address the cause of the deviation and do not ensure that affected product does not enter commerce. We acknowledge that you have added the CCP of the (b)(4) as your previous HACCP plan addressed only three CCPs. However, your response is not adequate because your HACCP plan still does not address the cause of the deviation as required by 21 CFR 120.10(a)(2).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) 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 such as validations studies, HACCP plans 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.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug and Cosmetic Act and all applicable regulations.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with re-inspection. A re-inspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Re-inspection costs include 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. FDA will assess and collect fees associated with this re-inspection in accordance with Section 743 of the Act.
Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance officer, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issue in this letter, please contact Mr. Rabe at 513-679-2700 ext. 2163 or firstname.lastname@example.org.
Paul J. Teitell