FDA 483 - Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - January 22, 2018

An FDA inspection of Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd., an API manufacturer, revealed significant deficiencies in their quality systems. The firm was cited for incomplete investigations into out-of-specification results and equipment failures, as well as inadequate laboratory controls lacking scientifically sound procedures. Furthermore, the inspection identified insufficient validation of cleaning, manufacturing, and sealing processes, alongside ineffective equipment cleaning and maintenance practices.