FDA Inspection 869590 — Danville Regional Medical Center/Blood Bank
The FDA completed an inspection of Danville Regional Medical Center/Blood Bank on Mar 3, 2014 in Danville, VA. 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 3, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Danville, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9596 | 21 CFR 640.3(a) | Donor suitability by means of medical history |
| 98 | 21 CFR 606.100(c) | Thorough investigations |