FDA Inspection
Philips Medical Systems (Cleveland) IncPhilips Medical Systems (Cleveland) Inc – FDA Inspection, Jun 14, 2010
Record Details
This FDA Inspection record concerns Philips Medical Systems (Cleveland) Inc, with an inspection on June 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 14, 2010
- Product Type
- Devices
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ID · d042752b-b5b6-4c7b-81e8-1d69a117d801
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666779
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.40Procedures not adequately established or maintained
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Other FDA inspections of Philips Medical Systems (Cleveland) Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| November 26, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 4, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 24, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips Medical Systems (Cleveland) Inc
- FDA Inspection 1260011 - 2025-01-16
- FDA Inspection 1111084 - 2019-11-26
- FDA Inspection 1091789 - 2019-06-04
- FDA Inspection 1072883 - 2018-10-24
- FDA Inspection 1022578 - 2017-08-18
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