FDA Inspection 1107397 — MedStar Georgetown Medical Center Inc Georgetown University Hospital
The FDA completed an inspection of MedStar Georgetown Medical Center Inc Georgetown University Hospital on September 10, 2019 in Washington, DC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 10, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Washington, DC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |