FDA 483 - Thuan Thien Producing Trading Limited Company - September 08, 2023

During an inspection conducted from September 7-8, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Thuan Thien Producing Trading Limited Company, a manufacturer located in Long An City, Vietnam. The observations detailed non-compliance with regulations concerning pathogen reduction processes for several frozen juice products, including coconut, passion fruit, calamansi, and lime juices. The primary finding was the company's failure to conduct a 5-log pathogen reduction process for these juices within its own facility, as required. Instead, juices were extracted, filled, and then sent to external facilities for treatment before being returned for distribution. Critically, Thuan Thien lacked data to validate that these external treatments effectively delivered the mandatory 5-log pathogen reduction. Additionally, the inspection revealed deficiencies in the company's Hazard Analysis and Critical Control Point (HACCP) plans. Specifically, the HACCP plans for all inspected frozen juice products, dated January 1, 2018, did not incorporate the necessary control measures to consistently achieve a 5-log pathogen reduction for significant microorganisms. These observations indicate a need for the company to review and revise its production processes and HACCP documentation to ensure compliance with U.S. food safety standards, particularly those pertaining to juice processing. The company is expected to implement corrective actions in response to these findings.