FDA Inspection 553235 — Elkhart General Hospital Blood Donor Center
The FDA completed an inspection of Elkhart General Hospital Blood Donor Center on Dec 10, 2008 in Elkhart, IN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 10, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 163 | 21 CFR 606.165(b) | Distribution records - content |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |