FDA 483 - G.N.R. Group Co., LTD. - January 23, 2024

An FDA inspection of G.N.R. Group Co., LTD., a juice manufacturer in Yan Nawa, Bangkok, Thailand, was conducted from January 22-23, 2024. The inspection resulted in a Form FDA 483, detailing observations related to the company's Hazard Analysis and Critical Control Point (HACCP) plan for products like "Frozen Coconut Juice with Pulp" intended for export to the United States. Key issues identified include the HACCP plan's failure to incorporate control measures for achieving a 5-log reduction in microorganisms of public health significance. Additionally, the plan did not list critical control points for undeclared allergens and the "keep frozen" statement, which were noted as repeat observations from a previous inspection in May 2019. The firm also failed to validate its HACCP plan annually, another repeated observation. These findings indicate a need for G.N.R. Group Co., LTD. to enhance its food safety management systems to meet U.S. regulatory standards. The company is expected to respond to these observations by outlining corrective actions to address the identified deficiencies in its HACCP program and ensure product safety and proper labeling.