FDA Inspection 807124 — VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L)
The FDA completed an inspection of VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L) on November 16, 2012 in Pittsburgh, PA. 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
- November 16, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |