FDA inspection
MaineHealth IRB #1: FDA inspection ending Mar 16, 2016
FDA inspection 962618 · Voluntary Action Indicated (VAI) · Portland, ME
Key facts
| Inspection ID | 962618 |
|---|---|
| Firm | MaineHealth IRB #1 |
| FEI number | 3003354649 |
| Address | Maine Medical Center Research Institute, 81 Research Dr |
| City | Portland |
| State | ME |
| ZIP | 04101 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Mar 16, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data