Juice Tyme, Inc. – FDA Warning Letter, Sep 30, 2010

The FDA inspected Juice Tyme, Inc.'s facility from July 20 to September 30, 2010, revealing serious deviations from juice HACCP (21 CFR Part 120) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The "Premium Orange 4 + 1 with Pulp" product was deemed adulterated due to insanitary conditions.

Key violations include: 1. **Juice HACCP Plan Deficiency:** The HACCP plan for "Premium Orange 4 + 1 with Pulp" lacked control measures to achieve a 5-log reduction in pertinent microorganisms, as required by 21 CFR 120.24(a). The provided study did not ensure product safety or identify critical factors for the 5-log reduction. 2. **GMP Monitoring Failures:** The firm failed to sufficiently monitor conditions and cleanliness of food contact surfaces, prevent cross-contamination, protect food/packaging from adulteration, and exclude pests (21 CFR 120.6(b)). Evidence included observed fly-like insects in processing/packaging areas on multiple dates, damaged and taped packaging for lemon concentrate, and a dead fly-like insect in a lemon juice concentrate container.

Additionally, as a manufacturer of acidified food products (Thickened Water Nectar, Lemon, Honey), Juice Tyme, Inc. violated 21 CFR Part 108 and