FDA Inspection 576907 — BioElectronics Corporation
The FDA completed an inspection of BioElectronics Corporation on April 28, 2009 in Frederick, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Frederick, MD (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 2997 | 21 CFR 812.140(b)(4)(ii) | Sponsor records re non-significant risk status inadequate |
| 3000 | 21 CFR 812.140(b)(4)(v) | Sponsor records re QSR/GMP & non-significant risk studies |
| 3043 | 21 CFR 812.150(b)(2) | Sponsor notification of IRB approval withdrawal |
| 3048 | 21 CFR 812.150(b)(5) | Sponsor progress reports for non-significant risk study |