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

Source: https://www.globalkeysolutions.net/records/483/philips-healthcare-suzhou-co-ltd/0310d8ff-abe3-4844-8dcf-97c933462eb3

> FDA 483 for Philips Healthcare (Suzhou) Co., Ltd. on October 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Inspection Date: 2023-10-23
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [Maryann Tabalante](https://www.globalkeysolutions.net/people/maryann-tabalante/2ffb4259-9d6f-46b3-86df-adbc9cc543f6)

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-suzhou-co-ltd/f697ee6b-76f7-4128-9e8c-71e7ebe08572

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321