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

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.