FDA Inspection 834824 — Johnston Memorial Hospital, Inc.
The FDA completed an inspection of Johnston Memorial Hospital, Inc. on June 21, 2013 in Abingdon, VA. 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
- June 21, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Abingdon, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 98 | 21 CFR 606.100(c) | Thorough investigations |