FDA WARNING_LETTER - Vital Juice Company, Inc. - November 21, 2014

The FDA inspected a juice processing facility in Seattle, Washington, from November 19-21, 2014, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). This renders the firm's 100% juice blends and 60-90% juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate 5-log reduction validation:** The HACCP plan's critical limits for 100% and 60-90% juice products were not validated to achieve a 5-log reduction of pertinent microorganisms, as required by 21 CFR Part 120.24. A validation study was inadequate, failing to show a 5-log reduction for several products and not identifying pertinent microorganisms. A second study on "vital greens" used parameters not routinely met by the product's pH, and no validation was conducted for the current HPP treatment. 2. **Missing critical control points/limits:** The HACCP plan for "Fresh Squeezed and Cold-Pressed Fruit and Vegetable Juices" did not identify blending/filling as a critical control point or list pH 4.6 at this step to control *Clostridium botulinum*, violating 21 CFR