FDA Inspection
Philips North America, LLCPhilips North America, LLC – FDA Inspection, Dec 4, 2018
Record Details
This FDA Inspection record concerns Philips North America, LLC, with an inspection on December 4, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7cfa23ca-eaf3-4f8e-8fd6-89f749c32998
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1073570
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Philips North America, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2019 | Not classified | New England District Office | |
| July 14, 2017 | Not classified | New England District Office | |
| June 18, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips North America, LLC
- FDA Inspection 1260630 - 2025-01-16
- FDA Inspection 1142575 - 2019-08-23
- FDA Inspection 1034836 - 2017-07-14
- FDA Inspection 932660 - 2015-06-18
- FDA Inspection 860079 - 2013-12-12
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