FDA Inspection 775678 — Bolton Medical Inc.
The FDA completed an inspection of Bolton Medical Inc. on March 6, 2012 in Sunrise, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Sunrise, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14521 | 21 CFR 812.36(e) | No IRB approval for treatment use |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |