FDA WARNING_LETTER - Naturefield Company Limited

The FDA issued a Warning Letter to Naturefield Company Limited following a review of their HACCP documentation for 100% coconut water, prompted by import data indicating routine shipments to the U.S. The review revealed a serious violation of the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation, 21 CFR Part 120. Specifically, the firm's HACCP plan for their low-acid 100% coconut water does not include control measures to consistently achieve a 5-log reduction of the pertinent microorganism, Clostridium botulinum, as required by 21 CFR 120.24(a). This deficiency renders the product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Naturefield Company Limited is required to respond within fifteen working days, providing a revised HACCP plan, five consecutive days of monitoring records, and any additional information demonstrating full compliance. Failure to adequately respond may result in further FDA action, including refusal of admission and detention without physical examination of their coconut water products under Section 801(a) of the Act, potentially under Import Alert #20-07. The firm is reminded of its responsibility to comply with all applicable regulations, including 21 CFR 110 (CGMP).