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

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

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Record Details

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.

Company: Philips Healthcare (Suzhou) Co., Ltd.
Inspection Date: October 23, 2023
Product Type: Device
Office: International Compliance Team
Person: Maryann Tabalante

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ID · 0310d8ff-abe3-4844-8dcf-97c933462eb3