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  5. Stewart Brothers, Inc. - 03/25/2015
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Stewart Brothers, Inc.

Stewart Brothers, Inc.

United States

Issuing Office:
Seattle District Office

United States


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

Public Health Service
Food and Drug Administration
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA  98021-4425
Telephone:   425-302-0340
FAX:   425-302-0402


March 25, 2015
In reply refer to Warning Letter SEA 15-11
Ronald T. Stewart, President and Owner
Stewart Brothers, Inc.
3610 Central Vale Road
Hood River, Oregon 97031
Dear Mr. Stewart:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility located at 3610 Central Vale Road, Hood River, Oregon, on November 5 – 7, and 12, 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 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 “Kale Apple Lemon Greens,” “Green Apple Greens,” and “Lemon Ginger Apple Greens,” 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 November 19, 2014, response to the FDA-483, which includes corrective actions you have taken in response to violations listed on the FDA-483 and additional deviations discussed with you at the close of the inspection. However, your response does not fully address the violations observed during the inspection. After review of the inspectional findings and your firm’s response, your firm’s significant violations remain as follows:
  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 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 HACCP plan titled “Fresh Juice HPP HACCP Plan” references critical limits that have not been validated to achieve a 5-log reduction of the pertinent microorganisms for each of your 100% juice products that receive an HPP treatment (“Kale Apple Lemon Greens,” “Green Apple Greens,” and “Lemon Ginger Apple Greens,”), as required by 21 CFR 120.24(a).
Your response is not adequate in that you have not conducted, or committed to conducting, a validation study for each of your juice products that receive an HPP treatment to obtain a 5-log reduction of pertinent microorganisms that may be present in your 100% juice products. 
In addition, we note that your 100% juice blends, made from purees of kale, celery, spinach, cucumber, parsley, chard, etc., are all low acid juices, and the pertinent microorganism for these juices is Clostridium botulinum (C. botulinum).  HPP is not effective to control C. botulinum spores in low acid juices (i.e. pH above 4.6) and therefore, controls for C. botulinum in these low acid juice ingredients used in any juice blend or beverage is pH.  We acknowledge that your firm appears to monitor pH of your juice products as a final quality specification; however, your use of low acid juice ingredients that are susceptible to the growth of C. botulinum and toxin formation unless pH is controlled necessitates a critical control point for pH.
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 violations. 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 these 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
District Director
cc: Oregon State Department of Agriculture
      Food Safety Division
      635 Capitol Street NE
      Salem, Oregon 97301
      James D. Stewart, Secretary and Owner
      Stewart Brothers, Inc.
      3610 Central Vale Road
      Hood River, Oregon 97031


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