FDA Inspection 645763 — Central Texas Veterans Health Care System
The FDA completed an inspection of Central Texas Veterans Health Care System on Feb 12, 2010 in Temple, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 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 |