Wu's Tech (Vietnam) Co., Ltd.August 2, 2018

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

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Record Details

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.

Company: Wu's Tech (Vietnam) Co., Ltd.
Inspection Date: August 2, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Thai T. Duong

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ID · 1d276e00-a86e-4eea-a5dc-9c8e0b29ac79