FDA WARNING_LETTER - Harmless Harvest Thailand

The FDA issued a Warning Letter to Harmless Harvest Thailand for serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation (21 CFR Part 120) concerning their 100% Raw Coconut Water products. The FDA's review of provided documentation, including a microfiltration validation study and HACCP plans, revealed the products are processed in a manner that renders them adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan and Validation:** The firm's HACCP plan for coconut juice products failed to include control measures to consistently achieve a 5-log reduction in pertinent microorganisms, specifically *Clostridium botulinum*, as required by 21 CFR 120.24(a). The validation study for their microfiltration process did not adequately demonstrate a 5-log reduction of *Clostridium botulinum*, and the study revealed issues with the initial amount of inoculated bacteria and the final reduction. *Clostridium botulinum* is a critical hazard for low-acid juices like coconut water due to its potential to produce deadly toxins. 2. **Insufficient Sanitation Standard Operating Procedure (SSOP):** The firm's SSOP did not adequately address the safety of water in contact with food or food contact surfaces, nor the protection of food and packaging from biological contaminants (21 CFR 120.6(a)(