FDA WARNING_LETTER - Pat's Exotic Beverages, Inc. - February 11, 2015

The FDA inspected Pat's Exotic Beverages, Inc. from January 21 to February 11, 2015, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and misbranding issues. The firm's tamarind, carrot, carrot-lime, carrot-beet, and cucumber juice products are deemed adulterated due to insanitary conditions.

Key HACCP violations include: 1. Failure to validate a minimum 5-log reduction of pertinent microorganisms (e.g., *Clostridium botulinum* for low-acid juices) during pasteurization, as required by 21 CFR 120.24(a). The firm's process of boiling whole carrots and then juicing them was deemed inadequate. 2. HACCP plans (for carrot and carrot-beet juice) did not list allergens (milk) as a food safety hazard (21 CFR 120.8(b)(1)). 3. The cucumber juice HACCP plan lacked a critical control point for metal fragments, despite identifying it as a hazard (21 CFR 120.8(b)(2)). 4. Inadequate monitoring procedures and frequencies for critical control points, lacking details on methods, locations, and devices for temperature monitoring (21 CFR 120.8(b)(4)).