FDA EIR - Shanghai Tianyuan Plant Products Co., Ltd. - May 08, 2019

An FDA inspection of Shanghai Tianyuan Plant Products Co., Ltd., a foreign manufacturer of dietary supplement ingredients and blends, was conducted from May 6-8, 2019. The inspection, carried out under regulatory frameworks including 21 CFR Part 111 and 21 CFR Part 117, identified significant deviations from good manufacturing practices. Key violations included inadequate sanitation controls, evidenced by excessive debris on equipment (including spray dryers that contaminated finished products), unclean processing lines, and insufficient handwashing facilities. The company also lacked comprehensive training and implementation of 21 CFR Part 111 for dietary supplements, leading to failures in ensuring the identity and purity of ingredients and finished products, such as a Milk Thistle blend incorrectly declared as a single herbal extract. Batch records were incomplete, missing vital information, and laboratory operations lacked necessary electronic controls. Verbal deficiencies noted inadequate environmental monitoring, oversized warehouse air vent mesh, failure to record all customer complaints, and general campus disarray. Management, led by Mr. Yongning Yang, acknowledged the observations and committed to implementing corrective actions, including employee training, improving sanitation, enhancing environmental monitoring, and rectifying documentation practices. A written response to the FDA 483 observations was promised within 15 business days. The firm was previously under an Import Alert for pesticides.