FDA Inspection
Vestibular Research and Development LLC dba BalancebackVestibular Research and Development LLC dba Balanceback – FDA Inspection, Aug 19, 2015
Record Details
This FDA Inspection record concerns Vestibular Research and Development LLC dba Balanceback, with an inspection on August 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 19, 2015
- Product Type
- Devices
View Company Profile
ID · ba3019ea-582f-46a9-9577-3ff88fecdf02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938653
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vestibular Research and Development LLC dba Balanceback
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vestibular Research and Development LLC dba Balanceback
- FDA Inspection 1199454 - 2023-03-06
- FDA Inspection 841643 - 2013-07-25
- FDA Inspection 638153 - 2010-01-08
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.