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

During an FDA inspection, Flextronics Electronics Technology (Suzhou) Co., Ltd., a foreign medical device contract manufacturer, received two observations. The firm was cited for inadequately established and implemented procedures for corrective and preventive actions, including insufficient root cause analysis and verification of effectiveness. Additionally, the company failed to adequately control nonconforming products, specifically by not extending investigations to all affected areas and lacking complete documentation for rework activities.