FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - August 07, 2017

Zhejiang Hisun Pharmaceutical Co., Ltd., an API/Finished Drug Product Manufacturer in Taizhou, China, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to ensure data integrity in laboratory records, maintain adequate equipment cleaning procedures, and appropriately monitor storage conditions. Additionally, issues included a lack of contemporaneous record-keeping, insufficient documentation for manufacturing process changes and microbial limit testing, incomplete process validation studies, and poor facility maintenance in API storage areas.