FDA Inspection 787512 — St. Vincent Hospital And Health Care Inc.
The FDA completed an inspection of St. Vincent Hospital And Health Care Inc. on Jun 20, 2012 in Indianapolis, IN. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 20, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 198 | 21 CFR 640.2(c)(3) | Blood not stored between 1-6 deg / shipped 1-10 deg |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |