Company
United StatesVestibular Research and Development LLC dba Balanceback, Kettering, OH – FDA Inspections
Inspection records and compliance data for Vestibular Research and Development LLC dba Balanceback in Kettering, Ohio. 4 FDA inspections on record, last inspected March 06, 2023.
Company Profile
This profile covers Vestibular Research and Development LLC dba Balanceback based in Kettering, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 8, 2010. Last inspected March 6, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Management review - defined interval, sufficient frequency1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 6, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1199454 |
| August 19, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938653 |
| July 25, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 841643 |
| January 8, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 638153 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Vestibular Research and Development LLC dba Balanceback
FEI Number
3005049286
Address
2090 Hewitt Ave, Kettering, Ohio 45440, United States
Country
United States
ID: c3fa244e-256b-4e24-a56a-edfa7693545f