FDA 483 - NingBo Huize Commodity Co.,Ltd. - March 22, 2019

An FDA inspection of NingBo Huize Commodity Co.,Ltd. in Yuyao, China, a drug manufacturer, revealed significant deficiencies in its quality control unit and manufacturing processes. The firm was cited for providing false documentation and data, lacking essential validation programs, and failing to establish adequate laboratory and production controls. These observations indicate a severe lack of adherence to good manufacturing practices, impacting the identity, strength, quality, and purity of drug products.