FDA inspection
Philips Healthcare (Suzhou) Co., Ltd.: FDA inspection ending Oct 26, 2023
FDA inspection 1223101 · Suzhou
Key facts
| Inspection ID | 1223101 |
|---|---|
| Firm | Philips Healthcare (Suzhou) Co., Ltd. |
| FEI number | 3009529630 |
| Address | Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang |
| City | Suzhou |
| Fiscal year | 2024 |
| Inspection end date | Oct 26, 2023 |
| Project area | Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority |
| Product type | Devices |
| Warning letter | 676605 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data