FDA 483 - Henan Lvyuan Pharmaceutical Co., Ltd. - September 26, 2025
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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.
ID · 67b3a61c-67b2-421a-ba84-15338f02d5d9