FDA WARNING_LETTER - Stewart Brothers, Inc. - November 12, 2014

The FDA inspected Stewart Brothers, Inc.'s juice processing facility in Hood River, Oregon, from November 5-7 and 12, 2014, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). Specifically, the firm's 100% juice blends, "Kale Apple Lemon Greens," "Green Apple Greens," and "Lemon Ginger Apple Greens," were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

The primary violation identified was the failure to include control measures in the HACCP plan to consistently achieve a 5-log reduction of pertinent microorganisms, as required by 21 CFR 120.24(a). The "Fresh Juice HPP HACCP Plan" referenced critical limits that were not validated for a 5-log reduction for products receiving High Pressure Processing (HPP) treatment. The firm's November 19, 2014, response to the FDA-483 was deemed inadequate as it did not include or commit to a validation study for each HPP-treated juice product.

Furthermore, the FDA noted that the low-acid juice blends (pH above 4.6), made from purees of kale, celery, spinach, etc., are susceptible to *Clostridium bot