FDA Inspection 1013357 — Stratton VA Medical Center
The FDA completed an inspection of Stratton VA Medical Center on April 28, 2017 in Albany, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Albany, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |