FDA 483 - Shandong Ruiying Pioneer Pharmaceutical Co., Ltd - March 18, 2019

An FDA inspection of Shandong Ruiying Pioneer Pharmaceutical Co., Ltd. in Heze City, China, from March 18-22, 2019, revealed two significant observations. The firm was cited for inadequate qualification of equipment used in API manufacturing. Additionally, deficient warehouse cleaning practices were observed, including rust, heavy dust accumulation, and a lack of cleaning records.