FDA Inspection 756146 — George E Wahlen VA Medical Center Transfusion Service MC113
The FDA completed an inspection of George E Wahlen VA Medical Center Transfusion Service MC113 on December 7, 2011 in Salt Lake City, UT. 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
- December 7, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |