FDA Inspection 753196 — UNM Hospitals
The FDA completed an inspection of UNM Hospitals on October 13, 2011 in Albuquerque, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 13, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 117 | 21 CFR 606.121(f) | Labeling of blood products unsuitable for transfusion |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |