FDA Inspection 729868 — Department Of The Army
The FDA completed an inspection of Department Of The Army on June 9, 2011 in Fort Irwin, CA. 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
- June 9, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Irwin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |