FDA WARNING_LETTER - Target Agriculture (Pvt) Ltd. - June 10, 2015

The FDA inspected Target Agriculture, Ltd.'s juice processing facility in Sri Lanka on June 9-10, 2015, identifying serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 120). The firm's organic frozen graviola juice products were deemed adulterated under Section 402(a)(4) of the Food, Drug and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Inadequate Critical Limits (21 CFR 120.8(b)(3)):** The HACCP plan for organic frozen graviola juice lacked a processing time for the "Pasteurization" critical control point, failing to ensure a minimum 5-log pathogen reduction for *Salmonella* and *E. coli*. 2. **Inadequate Monitoring Procedures (21 CFR 120.8(b)(4)):** The monitoring procedure for "Pasteurization" was insufficient, not recommending continuous monitoring of both time and temperature with a recording device. 3. **Inappropriate Corrective Actions (21 CFR 120.8(b)(5)):** The corrective action for "Pasteurization" deviations did not specify how the cause of the deviation would be corrected, as required by 21 CFR 120.10(a). 4. **Inadequate Sanitation Monitoring (21 CFR