FDA Inspection 1269585 — Department of Defense - Army
The FDA completed an inspection of Department of Defense - Army on May 9, 2025 in Fort Gordon, GA. 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
- May 9, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Gordon, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |