FDA Inspection
Philips North AmericaPhilips North America – FDA Inspection, Dec 13, 2023
Record Details
This FDA Inspection record concerns Philips North America, with an inspection on December 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c904f90c-ace0-49c7-b3f3-d5212e6e6fdb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Philips North America
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2017 | 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 1005211 - 2017-03-03
- FDA Inspection 777361 - 2012-04-13
- FDA Inspection 607750 - 2009-07-18
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