876385
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Westford, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |