FDA Inspection 669807 — Indiana University Health Ball Memorial Hospital, INC.
The FDA completed an inspection of Indiana University Health Ball Memorial Hospital, INC. on Jul 7, 2010 in Muncie, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 7, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Muncie, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 157 | 21 CFR 606.160(d) | Retention period |
| 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 |