FDA Inspection
Elkhart General Hospital Blood Donor CenterFDA Inspection 553235 - Elkhart General Hospital Blood Donor Center - December 10, 2008
Record Details
This FDA Inspection record concerns Elkhart General Hospital Blood Donor Center, with an inspection on December 10, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 10, 2008
- Product Type
- Biologics
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ID · 65d48fe3-e93e-494f-93c5-0b3518a0f6b8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 553235
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 606.165(b)Distribution records - content
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Elkhart General Hospital Blood Donor Center
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Elkhart General Hospital Blood Donor Center
- FDA Inspection 641884 - 2010-01-25
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