FDA Inspection 1059131 — Department of Defense - Army
The FDA completed an inspection of Department of Defense - Army on July 17, 2018 in Tripler Army Medical Center, HI. 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
- July 17, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tripler Army Medical Center, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 9256 | 21 CFR 610.41 | Donor Deferral |