FDA 483 - Zhangzhou Aoxi Plastics Co., Ltd. - December 06, 2017

An FDA inspection of Zhangzhou Aoxi Plastics Co., Ltd. in Zhangzhou, China, a medical device manufacturer, revealed a significant issue regarding process validation. The firm failed to adequately validate processes for manufacturing hospital disposable devices. This indicates a lack of assurance in the consistency and quality of their production methods.