FDA Inspection 820198 — Veterans Affairs Medical Center
The FDA completed an inspection of Veterans Affairs Medical Center on February 20, 2013 in Battle Creek, MI. 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
- February 20, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Battle Creek, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 87 | 21 CFR 606.100(b)(8) | Methods for pre-transfusion testing |