FDA Inspection 721822 — Department of Defense - Army
The FDA completed an inspection of Department of Defense - Army on April 22, 2011 in Ft Wainwright, AK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Ft Wainwright, AK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |