FDA Inspection 645763 — Central Texas Veterans Health Care System
The FDA completed an inspection of Central Texas Veterans Health Care System on February 12, 2010 in Temple, TX. 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
- February 12, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Temple, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |