FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - June 28, 2019

An FDA inspection of Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, China, from June 24-28, 2019, revealed significant deficiencies in equipment maintenance. The firm was cited for inadequate preventive maintenance of its (b)(4) tanks, specifically noting issues with loose plastic tape and old, worn-out seals. These observations indicate a lapse in quality control regarding the upkeep of critical manufacturing equipment.