FDA Inspection
Elmhurst Hospital CenterElmhurst Hospital Center – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Elmhurst Hospital Center, with an inspection on June 24, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Elmhurst Hospital Center
- Inspection Date
- June 24, 2016
- Product Type
- Biologics
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ID · 626de8e4-770c-495a-93eb-2b5c061bc077
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974715
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 606.40Suitable size, construction, etc.
- 21 CFR 600.12(a)Maintenance - tracing
- 21 CFR 606.100(b)SOPs for investigations, records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| February 27, 2014 | 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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