FDA Inspection 709050 — Aderans Research Institute
The FDA completed an inspection of Aderans Research Institute on February 9, 2011 in Marietta, GA. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Marietta, GA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7507 | 21 CFR 312.52(a) | Transfer of obligations |