FDA Inspection 829171 — Community Blood Bank of Erie County
The FDA completed an inspection of Community Blood Bank of Erie County on April 26, 2013 in Erie, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 236 | 21 CFR 640.5(e) | Testing - inspection |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9596 | 21 CFR 640.3(a) | Donor suitability by means of medical history |
| 98 | 21 CFR 606.100(c) | Thorough investigations |