FDA Inspection
Elmhurst Hospital CenterElmhurst Hospital Center – FDA Inspection, Feb 1, 2019
Record Details
This FDA Inspection record concerns Elmhurst Hospital Center, with an inspection on February 1, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c53082d2-129c-4de1-9895-f14535c96064
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078094
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required 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 |
|---|---|---|---|
| June 24, 2016 | 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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