Dragon Heart Medical Devices Co., Ltd.September 13, 2018

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

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Record Details

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.

Company: Dragon Heart Medical Devices Co., Ltd.
Inspection Date: September 13, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Thai T. Duong

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