FDA 483 - Samchundang Pharm Co., Ltd. - May 19, 2026

The FDA inspected Samchundang Pharm Co., Ltd. in Hwaseong, Korea, a sterile drug manufacturer, from May 11-19, 2026. The inspection revealed significant deficiencies in aseptic processing, including inadequate validation of aseptic processes, poor aseptic practices, and insufficient environmental monitoring. The firm also failed to adequately investigate complaints involving microbial contamination and had an inadequate visual inspector qualification program.