FDA WARNING_LETTER - Sol-ti, Inc. - February 08, 2023

The FDA inspected a juice facility from December 19, 2022, to February 8, 2023, identifying serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render the ready-to-drink (RTD) juice products and juice ingredients adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan for 5-log Reduction (21 CFR 120.24(a)):** The UV Treatment critical control point (CCP) for SuperShot and SuperAde products lacks validation to consistently achieve a 5-log reduction of pertinent microorganisms (e.g., *Cryptosporidium parvum*, *E. coli O157:H7*, *Salmonella*) for both 100% juice products and juice ingredients in beverages. The firm's response, citing future validation studies and HACCP training, was deemed incomplete due to lack of evidence. 2. **Incomplete Hazard Analysis (21 CFR 120.8(b)(1)):** HACCP plans for SuperShot and SuperAde products do not list all reasonably likely food hazards, including various biological, chemical, and physical hazards. The firm's proposed corrective actions, including updated hazard analyses and testing,