Company
United StatesFluke Biomedical LLC, Everett, WA – FDA Inspections
Inspection records and compliance data for Fluke Biomedical LLC in Everett, Washington. 7 FDA inspections on record, last inspected January 18, 2024.
Company Profile
This profile covers Fluke Biomedical LLC based in Everett, Washington, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected August 3, 2010. Last inspected January 18, 2024.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design history file1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 18, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1227243 |
| November 21, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1191060 |
| December 18, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1114053 |
| December 14, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 995390 |
| December 12, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 906946 |
| November 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 806940 |
| August 3, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 676337 |
FDA documents
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Company Information
Name
Fluke Biomedical LLC
FEI Number
2921581
Address
6920 Seaway Blvd, Everett, Washington 98203, United States
Country
United States
ID: 70d6902b-4b77-4efb-92de-34ebe4e2ef01