FDA Inspection 777775 — MedStar Georgetown Medical Center Inc Georgetown University Hospital
The FDA completed an inspection of MedStar Georgetown Medical Center Inc Georgetown University Hospital on April 26, 2012 in Washington, DC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Washington, DC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 98 | 21 CFR 606.100(c) | Thorough investigations |