FDA Inspection 648126 — MaineHealth IRB #1
The FDA completed an inspection of MaineHealth IRB #1 on Feb 12, 2010 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Portland, ME (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7270 | 21 CFR 56.103(a) | IRB review requirement |
| 7353 | 21 CFR 50.52 | Factors required for approval |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |