FDA WARNING_LETTER - Raya Green Coconut Co., Ltd. - March 15, 2024

The FDA conducted a remote regulatory assessment of Raya Green Coconut Co. in Thailand from March 11 to March 15, 2024, identifying serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation (21 CFR Part 120). These deviations render the firm's juice products, including frozen coconut water, adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. Specifically, the firm's HACCP plan for Frozen Coconut Water in Plastic Bag products fails to list Clostridium botulinum as a reasonably likely food hazard, violating 21 CFR 120.8(b)(1). Furthermore, the critical limits for the thermal process (b)(4)°C for (b)(4) minutes) are insufficient to achieve the required minimum 5-log reduction of C. botulinum, as mandated by 21 CFR 120.24(a), indicating an improperly developed thermal process without validation data. The firm's March 30, 2024, response to the FDA-483, which included a quotation for temperature distribution and heat penetration studies, was deemed inadequate as no updated HACCP plan or records of corrective actions have been provided. Raya Green Coconut Co. must respond within fifteen working days, outlining specific corrections with supporting documentation, including processing records for five product lots. Failure to adequately respond may result in refusal of admission of their juice products into the U.S. under Section 801(a) of the Act and detention without physical examination (DWPE), referencing Import Alert #20-07.