FDA 483 - Wu's Tech (Vietnam) Co., Ltd. - August 02, 2018

Wu's Tech (Vietnam) Co., Ltd. was inspected as a medical device manufacturer, revealing two significant issues. The firm failed to establish proper production procedures for the assembly of 4-Wheel Scooters and did not submit Medical Device Reports (MDRs) within 30 days for multiple serious injury complaints related to scooter tip-overs. These findings highlight critical deficiencies in quality system controls and post-market surveillance.