FDA 483 - Henan Lvyuan Pharmaceutical Co., Ltd. - September 26, 2025

Henan Lvyuan Pharmaceutical Co., Ltd. in Xinxiang County, China, an API manufacturer, received a Form FDA 483 for multiple significant quality system deficiencies. These included unvalidated analytical instruments and methods, inadequate contamination control, incomplete batch records, and a deficient quality control unit. Further observations noted poorly maintained equipment, improper equipment identification, and insufficient laboratory controls for microbiology media.