FDA 483 - Philips Healthcare (Suzhou) Co., Ltd. - October 23, 2023

An FDA inspection of Philips Healthcare Co Ltd in Suzhou, Jiangsu, CN, a manufacturer of medical devices, revealed significant quality system deficiencies. The firm failed to report field corrections, adequately verify corrective actions, and properly investigate product complaints. Additionally, a critical manufacturing process for a CT system component was not validated, indicating a lack of robust quality control.