Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021-4425
May 4, 2015
In reply refer to Warning Letter SEA 15-14
Chief Executive Officer
Vital Juice Company, Inc.
1519 Elliott Avenue West
Seattle, Washington 98119
Dear Mr. Balassanian:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility located at 1519 Elliott Avenue West, Seattle, Washington, on November 19 through 21, 2014. This inspection revealed 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 Part 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR 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 100% juice blends “vital greens,” “vital grapefruit,” “vital melon,” “vital beet,” “vital citrus,” “vital carrot,” “vital pineapple,” and “vital coconut water;” and your 60%-90% juice products, “vital almond w/citrus,” “vital almond w/carrot,” “vital almond w/greens,” “vital almond w/beet,” “Capt. Carrot,” “Mr. Squeeze,” “Green Gorilla,” and “Mrs. Beet” 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 on the FDA’s homepage at www.fda.gov.
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s December 15, 2014, response to the FDA-483, which included a validation study for your firm’s juice products. However, your response did not fully address the violations observed during the inspection. After review of the inspectional findings and your firm’s response, your firm’s significant deviations remain as follows:
- 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 as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR Part 120.24. However, your HACCP plan titled “For HPP of Fruit and Vegetable Juice” referenced critical limits that have not been validated to achieve a 5-log reduction of the pertinent microorganisms for each of your 100% juice products (“vital greens,” “vital grapefruit,” “vital melon,” “vital beet,” “vital citrus,” “vital carrot,” “vital pineapple,” and “vital coconut water”), or for the juice used in your 60-90% juice products (“vital almond w/citrus,” “vital almond w/carrot,” “vital almond w/greens,” “vital almond w/beet,” “Capt. Carrot,” “Mr. Squeeze,” “Green Gorilla,” and “Mrs. Beet”), as required by 21 CFR Part 120.24(a).
Your firm’s validation study, dated March 27, 2013, appears to be inadequate in that it indicates a 5-log reduction was not achieved for products tested and identified in the study report as “Watermelon,” “Grapefruit,” “Vital Greens,” “Pineapple/Ginger,” and “Tangerine,” and does not identify any pertinent microorganism targeted in each type of juice.
In addition, your firm’s second validation study, conducted solely on your “vital greens” product, has the HPP parameters of (b)(4) PSI for (b)(4) with a product pH of (b)(4). Review of your processing records indicates your product “vital greens” routinely achieves a pH of not less than 4.4. Further, review of your production records reveal that none of your juice products have a finished product pH of (b)(4) or less. While your current HPP treatment is conducted at a higher PSI for a longer period of time, you have not conducted a validation study that indicates this process is sufficient to achieve a 5-log reduction of pertinent microorganisms for each of your juice products.
- You must have a HACCP plan that lists the critical control points and critical limits that must be met, to comply with 21 CFR Part 120.8(b)(2) and (3). However, your firm's HACCP plan for “Fresh Squeezed and Cold-Pressed Fruit and Vegetable Juices” does not identify the blending/filling step as a critical control point, nor does it list the pH of 4.6 at this step as a critical limit to control Clostridium botulinum.
Additionally, your firm’s HACCP plan for “Coconut Water” lists a critical limit of “high pressure processing” at the (b)(4) High Pressure Processing (CCP)” critical control point that is not adequate to control Clostridium botulinum. HPP processing in the absence of high temperatures does not eliminate Clostridium botulinum spores. Your firm’s refrigeration measures are inadequate to control germination of non-proteolytic Clostridium botulinum spores and subsequent toxin formation.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with good manufacturing practice regulations, as required by 21 CFR Part 120.6(b). However, your firm did not monitor for protection of food, food packaging material, and food contact surfaces from adulteration with contaminants, or the proper labeling, storage and use of toxic compounds as indicated by the following:
a. An unlabeled spray bottle in the juicing area was identified by an employee to contain sanitizer.
b. Bottles containing sanitizers and cleaning agents were stored with clean, ready-to-use food production equipment.
Further, your firm did not maintain sanitation standard operating procedure records to document monitoring the eight key areas of sanitation between October 1, 2014, and November 5, 2014.
We may take further action if you do not promptly correct these violations. For instance, we may initiate a regulatory action without further formal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
Please respond in writing within fifteen (15) business days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these deviations. Include in your response documentation of the corrections your firm has taken, or other useful information that may assist us in evaluating your corrections. If you cannot complete all corrective actions within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
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)). 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 submit your response to the Food and Drug Administration, Attention LCDR Cynthia White, Compliance Officer at 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions regarding this letter, please contact LCDR White at (425) 302-0422.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504