Wu's Tech Co., Ltd.August 30, 2018

FDA 483 - Wu's Tech Co., Ltd. - August 30, 2018

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Record Details

Wu's Tech Co., Ltd. in Hsin-Chu, Taiwan, was inspected by the FDA, revealing issues with their manufacturing processes for medical devices. The inspection found that procedures for finished device acceptance were not adequately established, with discrepancies in specifications and undocumented verifications. Additionally, document control procedures were insufficient, leading to manufacturing forms not being properly safeguarded.

Company: Wu's Tech Co., Ltd.
Inspection Date: August 30, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Monica C. Burgos Garcia

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ID · bd1987e7-836d-48a9-953e-c4162764a23c