Company
United StatesPhilips North America LLC, Bothell, WA – FDA Inspections
Inspection records and compliance data for Philips North America LLC in Bothell, Washington. 13 FDA inspections on record (3 OAI), 4 Form 483s, last inspected November 21, 2025.
Company Profile
This profile covers Philips North America LLC based in Bothell, Washington, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 3
- VAI
- 6
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 4
- Warning letters
- 0
First inspected December 16, 2008. Last inspected November 21, 2025.
Most cited issue areas
- Lack of or inadequate procedures6 inspections
- Lack of or inadequate complaint procedures3 inspections
- Documentation2 inspections
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1292226 |
| November 6, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1236344 |
| November 3, 2023 | Not classified | Medical Devices & Rad Health | 1221815 |
| October 27, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1182153 |
| August 20, 2021 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1149323 |
| March 25, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1121760 |
| December 3, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1073302 |
| April 21, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 923916 |
| April 24, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 830352 |
| August 29, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 801680 |
| March 19, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 772990 |
| August 9, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 680783 |
| December 16, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 555781 |
FDA documents
People (4)
Related Companies (10)
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Company Information
Name
Philips North America LLC
FEI Number
1000524572
Address
22100 Bothell Everett Hwy, Bothell, Washington 98021, United States
Country
United States
ID: d7335702-bc34-4fb8-acdc-db91e81d2f8c