FDA Inspection 731944 — Ochsner Health System Blood Bank
The FDA completed an inspection of Ochsner Health System Blood Bank on Jun 17, 2011 in New Orleans, LA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Orleans, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 9225 | 21 CFR 606.171 | Biological product deviation report |