FDA Inspection 962618 — MaineHealth IRB #1
The FDA completed an inspection of MaineHealth IRB #1 on Mar 16, 2016 in Portland, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 16, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Portland, ME (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |