FDA 483 - Hubei Yitai Pharmaceutical Co., Ltd - December 13, 2024

Hubei Viti Pharmaceutical Co., Ltd, an API manufacturer in Tianmen, Hubei Province, China, was cited for significant deficiencies in its quality control systems. The inspection revealed a repeat failure to implement an adequate stability testing program for its API drug products and issues with laboratory controls. Specifically, the firm lacked suitable and verified analytical test methods for both finished products and critical raw materials.