Company
United StatesPhilips Ultrasound, Inc., Bothell, WA – FDA Inspections
Inspection records and compliance data for Philips Ultrasound, Inc. in Bothell, Washington. 5 FDA inspections on record (1 OAI), 3 Form 483s, last inspected January 31, 2025.
Company Profile
This profile covers Philips Ultrasound, Inc. based in Bothell, Washington, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected December 9, 2011. Last inspected January 31, 2025.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Complaints1 inspection
- Design validation - Risk analysis1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 31, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1253946 |
| November 10, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1157069 |
| July 25, 2019 | Not classified | Medical Devices & Rad Health | 1157003 |
| August 17, 2017 | Not classified | Medical Devices & Rad Health | 1028990 |
| December 9, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 761739 |
FDA documents
Form 483s (1)
- Form 483s · January 31, 2025
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Company Information
Name
Philips Ultrasound, Inc.
FEI Number
3019216
Address
22100 Bothell Everett Hwy, Bothell, Washington 98021, United States
Country
United States
ID: 36d048c6-d991-443c-b562-f9d7bacc8be8