FDA Inspection 995635 — Department Of Veterans Affairs Medical Center Laboratory Service Blood Bank
The FDA completed an inspection of Department Of Veterans Affairs Medical Center Laboratory Service Blood Bank on Dec 20, 2016 in Wilkes Barre, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wilkes Barre, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15041 | 21 CFR 610.47(b) | Lookback System [Consignee] |
| 38 | 21 CFR 606.40(b) | Adequate lighting, ventilation, and screening |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |