FDA 483 - Dragon Heart Medical Devices Co., Ltd. - September 13, 2018

Dragon Heart Medical Devices Co., Ltd. in Kaiping, China, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately validate its EO sterilization process and maintain associated production records. Additionally, the company did not establish adequate procedures for handling customer complaints, leading to several complaints not being entered into their system for investigation.