Company
United StatesEvergreen Orthopedic Research Lab, LLC, Kirkland, WA – FDA Inspections
Inspection records and compliance data for Evergreen Orthopedic Research Lab, LLC in Kirkland, Washington. 4 FDA inspections on record, 1 Form 483, last inspected April 12, 2019.
Company Profile
This profile covers Evergreen Orthopedic Research Lab, LLC based in Kirkland, Washington, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 5, 2011. Last inspected April 12, 2019.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1086103 |
| October 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 945848 |
| November 1, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 852501 |
| May 5, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 723717 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Evergreen Orthopedic Research Lab, LLC
FEI Number
3007190523
Address
11317 Ne 120th St, Kirkland, Washington 98034, United States
Country
United States
ID: d30446dc-b0a0-472b-8b40-e414590a00f1