FDA 483 - Flextronics Electronics Technology (Suzhou) Co., Ltd. - November 05, 2018

Flextronics Electronics Technology (Suzhou) Co., Ltd., a foreign medical device contract manufacturer, was inspected by the FDA from November 5-8, 2018. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions and the control of nonconforming products. These issues indicate a lack of adequately established and implemented procedures for ensuring product quality and preventing recurrence of problems.