FDA WARNING_LETTER - Garden of Flavor LLC - February 07, 2014

The FDA inspected Garden of Flavor, LLC's manufacturing facility from January 14-15 and February 4, 7, 2014, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render their 100% juice blends, including "Lemon Pepp" and "Mean Green," adulterated under Section 402(a)(4) of the Food Drug and Cosmetic Act.

Key violations include: 1. Lack of evidence for a 5-log reduction of pertinent microorganisms: The firm's validation studies for their (b)(4) process were inadequate, using a "cocktail" of microorganisms instead of a pertinent one for each juice, and not addressing Brix, acidity, or shelf-life under moderate abuse conditions. 2. HACCP plan not specific to each juice type: The firm used one HACCP plan for all juice products, failing to list hazards for each specific blend as required by 21 CFR 120.8(a)(2). 3. Insufficient monitoring of GMPs: The firm did not adequately monitor water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, protection from adulteration, toxic compound control, and employee health conditions. Their response lacked specified monitoring frequencies and records. 4. Inappropriate corrective actions: The corrective action