# FDA 483 - Philips Healthcare - VSS - Shanghai CDC - April 11, 2019

Source: https://www.globalkeysolutions.net/records/483/philips-healthcare-vss-shanghai-cdc/99dcfcb6-e620-4069-9bbb-70be10a984ee

> FDA 483 for Philips Healthcare - VSS - Shanghai CDC on April 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Healthcare - VSS - Shanghai CDC
- Inspection Date: 2019-04-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Philips Healthcare - VSS - Shanghai CDC, a medical device manufacturer in Shanghai, China, identified two observations related to inadequate procedures. The firm's procedures for design change did not adequately address root cause documentation for Post Release Change Requests. Additionally, their quality audit procedures lacked adequate detail regarding sample selection parameters.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-vss-shanghai-cdc/940073f5-25d4-4a30-9400-3097aaa3a478

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd