FDA 483 - Wu's Tech (Vietnam) Co., Ltd. - September 22, 2022

Wu's Tech (Vietnam) Co., Ltd., a medical device manufacturer in Thu Dau Mot City, Binh Duong Vietnam, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, medical device reporting (MDR), and labeling control. These issues indicate a lack of robust quality management practices for their medical devices.