FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - June 07, 2019

Zhejiang Hisun Pharmaceutical Co., Ltd. in Taizhou, Zhejiang, China, was inspected from June 3-7, 2019, revealing significant deficiencies in equipment maintenance, environmental monitoring, cleaning validation, and raw material storage. The inspection found corroded and dirty manufacturing equipment, an inadequate environmental monitoring SOP, a lack of microbiological testing in cleaning validation, and insect infestation in a raw material warehouse. These issues indicate a moderate level of severity concerning manufacturing controls and facility sanitation.