483
Dragon Heart Medical Devices Co., Ltd.Dragon Heart Medical Devices Co., Ltd. – FDA 483, Sep 13, 2018
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.
View Company Profile
ID · b3389d54-8989-47fb-8eea-0d62f2bd3ec9
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.