FDA 483 - Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd. - August 03, 2018

Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd., an API manufacturer in Fuqing, China, was cited for significant deficiencies during an FDA inspection. Observations included failures in microbial monitoring and control for non-sterile APIs, inadequate laboratory documentation for purity determination, and improper equipment calibration using non-traceable standards. The firm also failed to document sanitization parameters for materials used in API manufacturing, indicating systemic issues with quality control and good manufacturing practices.