FDA Inspection 930034 — Community Blood Bank of Erie County
The FDA completed an inspection of Community Blood Bank of Erie County on June 10, 2015 in Erie, 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
- June 10, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 98 | 21 CFR 606.100(c) | Thorough investigations |