Juices Enterprises Inc. – FDA Warning Letter, Nov 21, 2007

On November 13-21, 2007, the FDA inspected Juices Enterprises Inc., identifying serious violations of juice HACCP (21 CFR Part 120) and GMP (21 CFR Part 110) regulations, rendering products adulterated.

Key violations include: 1. **Temperature Control:** Failure to refrigerate "KEEP REFRIGERATED" carrot juice, observed unrefrigerated for 24 hours, and inadequate refrigeration space. (21 CFR 110.80(b)(3)) 2. **HACCP Plan:** Absence of a written hazard analysis and HACCP plan for carrot, pineapple, and other juices, and failure to include a 5-log reduction control for pertinent microorganisms like *Clostridium botulinum*. (21 CFR 120.7(a), 120.8(a), 120.24(a)) 3. **Sanitation Monitoring:** Inadequate monitoring of sanitation conditions. (21 CFR 120.6(h), 21 CFR Part 110) * **Hygienic Practices:** Employees observed with torn gloves and consuming food in the production area. (21 CFR 110.10(b)(5), (8)) * **Cross-Contamination:** Unidentified individuals in the production area,