Nikki's Ginger Tea LLC. – FDA Warning Letter, Nov 10, 2014

The FDA inspected Nikki's Ginger Tea LLC from October 22 to November 10, 2014, finding serious violations of Juice HACCP (21 CFR Part 120) and Current Good Manufacturing Practice (21 CFR Part 110) regulations, rendering products adulterated.

Key violations include: - **Juice HACCP:** No written HACCP plan or Hazard Analysis for ginger and carrot juice ingredients to control pathogen hazards (21 CFR 120.8(a), 120.7(a)). No Sanitation Standard Operating Procedure (SSOP) (21 CFR 120.6(a)). Failure to apply a 5-log reduction treatment for pertinent microorganisms (21 CFR 120.24(a)). - **GMPs:** Raw materials stored at improper temperatures (21 CFR 110.80(a)(5)). Equipment and containers (bottles, caps) stored in open containers on the floor, and a soiled refrigerator (21 CFR 110.80(b)(7)). Work-in-process (mixing pots) placed directly on the floor (21 CFR 110.80(b)(5)). - **Misbranding:** Product labels for "Nikki's Ginger Organic Carrot Apple," "Nikki's Ginger Organic Mint," and "Nikki's Ginger Organic Apple"