FDA 483 - Wuxi Medical lnstrument Factory Co., Ltd. - November 15, 2024

Wuxi Medical Instrument Factory Co., Ltd. in Wuxi, China, a sterile drug manufacturer, was cited with 10 observations during an FDA inspection. The observations highlight significant deficiencies across quality control, GMP training, sterile manufacturing processes, equipment maintenance, component testing, and stability programs, indicating a broad lack of adherence to CGMP requirements. The firm also failed to address previous FDA inspection observations.