FDA WARNING_LETTER - STPCA Inc. - October 05, 2022

The FDA inspected Sunten's facility from September to October 2022 and reviewed its website in February 2023, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products (Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2) are deemed unapproved new drugs due to disease treatment claims on the website. These products lack FDA approval for safety and effectiveness. Jian Shen, Xiao Yan, and Platcladus Leaves Ce Bai Ye are also misbranded as they require professional supervision, making adequate layperson directions impossible.

Dietary supplements like Lycium Formula Huan Shao Dan, Zinc, and another unnamed product are adulterated due to significant Current Good Manufacturing Practice (CGMP) violations. Sunten failed to establish adequate specifications for identity, purity, strength, and composition for components and finished products (21 CFR 111.70(a), (b)(1), (b)(2), (e)). The firm also failed to verify component identity and finished product specifications (21 CFR 111.73, 111.75(a)(1)(i), (c)), and lacked proper documentation for reference standards. Quality control personnel failed to reject out-of-specification products or conduct proper material reviews (21 CFR 111.113(a)(1),