FDA Inspection 899023 — 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 October 8, 2014 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |