822299
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Center Valley, PA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |