FDA Inspection
Elmhurst Hospital CenterElmhurst Hospital Center – FDA Inspection, Feb 27, 2014
Record Details
This FDA Inspection record concerns Elmhurst Hospital Center, with an inspection on February 27, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Elmhurst Hospital Center
- Inspection Date
- February 27, 2014
- Product Type
- Biologics
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ID · 370e2ea2-bfa4-4511-ae29-aef9a37cab7c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866528
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Elmhurst Hospital Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 24, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 30, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 2, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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