FDA Inspection 632319 — Wake Forest Baptist Health- Blood Bank Hospital
The FDA completed an inspection of Wake Forest Baptist Health- Blood Bank Hospital on November 19, 2009 in Winston Salem, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Winston Salem, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |
| 656 | 21 CFR 803.30(a)(1) | Report of Death Within 10 Days |