FDA 483 - Zhejiang Tianyu Pharmaceutical Co., Ltd. - November 29, 2024

During an inspection conducted from November 21-29, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Zhejiang Tianyu Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in China. The inspection revealed significant concerns regarding the company's laboratory control and quality systems, indicating deviations from regulatory expectations, likely Current Good Manufacturing Practices.

One primary observation highlighted a failure to establish an adequate impurity profile. The firm did not properly integrate and investigate known and unknown peaks during testing of recovered materials, consistently disregarding these impurities since 2019. Furthermore, procedures for tracking and evaluating unknown peaks were lacking for intermediates, raw materials, and recovered solvents/materials, leading to the sale of products without thorough impurity assessment.

A second critical issue involved the inadequate cleaning of equipment. The company failed to implement appropriate cleaning schedules for recovered solvent and material storage tanks, using them continuously without proper cleaning between changes in recovered materials. This practice posed a risk of contaminant and degradant carryover. Zhejiang Tianyu Pharmaceutical Co., Ltd. is expected to promptly address these observations to ensure compliance with FDA regulations and safeguard product quality.