FDA 483 - Qingdao Kangyuan Pharmaceutical Co. Ltd. - August 16, 2024

Qingdao Kangyuan Pharmaceutical Co. Ltd., an API drug manufacturer in Jiaozhou City, China, was cited for significant deficiencies across four observations during an FDA inspection. Issues included inadequate laboratory controls for water systems and raw material testing, incomplete master batch production records lacking critical time limits, unvalidated analytical methods, and poorly maintained manufacturing equipment showing flaking material and rust. These findings indicate a lack of robust quality systems to ensure product quality and purity.