FDA 483 - Shanghai STA Pharmaceutical Product Co., Ltd. - June 28, 2024

Shanghai STA Pharmaceutical Product Co., Ltd. in Shanghai was inspected and cited for significant deficiencies in quality control, production, and facility sanitation. Observations included inadequate investigation of out-of-specification results, lack of written procedures for critical process controls, and insufficient validation of fumigation procedures. These issues indicate a potential risk to drug product quality and purity.