Thuan Thien Producing Trading Limited Company – FDA Warning Letter, Sep 8, 2023

The FDA issued a Warning Letter to Thuan Thien Producing Trading Limited Company following an inspection from September 7-8, 2023, at their Vietnam facility, which manufactures various juices including Frozen Coconut, Passion Fruit, Pure Calamansi, and Lime Juices. The inspection revealed serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation (21 CFR Part 120), rendering their juice products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. The primary violation cited was the firm's failure to include control measures in their HACCP plans that consistently produce a minimum 5-log reduction in pertinent microorganisms, as required by 21 CFR 120.24(a). Specifically, the firm lacked documentation to demonstrate that their identified (b)(4) treatment achieved the required 5-log reduction for Frozen Passion Fruit, Pure Calamansi, and Lime Juices, with referenced scientific literature not covering their specific products. Furthermore, for Frozen Coconut Juice, a low-acid product where Clostridium botulinum is the pertinent microorganism, the proposed (b)(4) treatment was deemed inadequate to achieve the minimum 5-log reduction due to bacterial endospores' resistance to radiation. The FDA requires a written response within fifteen working days, detailing specific corrective actions, including supporting documentation like processing records for five product lots over five days. Failure to adequately respond may result in refusal of admission for their juice products into the U.S. under Section 801(a) of the Act, potentially leading to detention without physical examination (DWPE) and inclusion in Import Alert #20-07.