FDA Inspection 719338 — Veterans Administration Northern IN Healthcare System
The FDA completed an inspection of Veterans Administration Northern IN Healthcare System on April 8, 2011 in Marion, IN. 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 8, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Marion, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |