FDA Inspection
Philips North AmericaPhilips North America – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Philips North America, with an inspection on March 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e2cb00cf-409d-4f2c-b923-99f98a7a6b0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005211
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Philips North America
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 18, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips North America
- FDA Inspection 1224855 - 2023-12-13
- FDA Inspection 777361 - 2012-04-13
- FDA Inspection 607750 - 2009-07-18
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