FDA Inspection 893528 — Owensboro Health Regional Hospital
The FDA completed an inspection of Owensboro Health Regional Hospital on August 14, 2014 in Owensboro, KY. 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
- August 14, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Owensboro, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 65 | 21 CFR 606.65(c) | Testing of representative samples of reagent lots |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |