FDA Inspection 946397 — Ekso Bionics
The FDA completed an inspection of Ekso Bionics on September 11, 2015 in Richmond, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Richmond, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |
| 3038 | 21 CFR 812.150(b)(1) | Sponsor evaluation rpt not timely, distributed |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |