FDA 483 - Zencore Biologics Co., Ltd. - September 06, 2023

Zencore Biologics Co., Ltd. in Shanghai, China, a biological testing laboratory, received two observations during an FDA inspection. The firm was cited for inadequate laboratory controls related to reference standard storage impacting bioassay results and for insufficient maintenance and monitoring of liquid nitrogen storage tanks used for cell banks, which could compromise drug product quality and cell bank integrity.