FDA Inspection 739272 — Community Blood Bank of Erie County
The FDA completed an inspection of Community Blood Bank of Erie County on August 25, 2011 in Erie, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 25, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |