FDA Inspection 769506 — VA Maine Health Care System-Togus
The FDA completed an inspection of VA Maine Health Care System-Togus on Feb 22, 2012 in Augusta, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Augusta, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |