Company
United StatesWestone Laboratories, Inc., Colorado Springs, CO – FDA Inspections
Inspection records and compliance data for Westone Laboratories, Inc. in Colorado Springs, Colorado. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected November 15, 2017.
Company Profile
This profile covers Westone Laboratories, Inc. based in Colorado Springs, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 6, 2009. Last inspected November 15, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate organizational structure1 inspection
- Maintenance schedule, Lack of or inadequate schedule1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1031336 |
| January 14, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 814099 |
| July 12, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 790503 |
| April 6, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 579412 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Westone Laboratories, Inc.
FEI Number
2094377
Address
2235 Executive Cir, Colorado Springs, Colorado 80906, United States
Country
United States
ID: 7a40b1c8-9133-4d76-a102-0d88ae07f7ae