FDA WARNING_LETTER - G.N.R. Group Co., LTD. - January 23, 2024

The FDA inspected a food manufacturing facility in Bangkok, Thailand, from January 22-23, 2024, which produces frozen fruits, vegetables, and coconut juice. The inspection revealed serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation (21 CFR Part 120), rendering the juice products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

The primary violation identified was the failure to include control measures in the HACCP plan for Frozen Coconut Juice that consistently produce a minimum 5-log reduction in the pertinent microorganism, as required by 21 CFR 120.24(a). Specifically, the pasteurization critical limits for coconut meat and water (b)(4) degrees Celsius for (b)(4) seconds were deemed insufficient for low-acid Frozen Coconut Juice, where *Clostridium botulinum* (non-proteolytic) is the pertinent microorganism. The firm's cited supporting article also indicated a more severe pasteurization process is needed for low-acid juices.

The FDA requires the firm to engage a process authority to develop a thermal process ensuring a 5-log reduction of non-proteolytic *Clostridium botulinum* and provide efficacy data. The firm must respond within fifteen working days, detailing corrective actions, prevention measures, and supporting documentation. Failure to comply may result in refusal of admission of products into