FDA Inspection
Elmhurst Hospital CenterElmhurst Hospital Center – FDA Inspection, Sep 30, 2010
Record Details
This FDA Inspection record concerns Elmhurst Hospital Center, with an inspection on September 30, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Elmhurst Hospital Center
- Inspection Date
- September 30, 2010
- Product Type
- Biologics
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ID · bad9a532-6212-4731-8605-c7ba210b1539
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682472
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
12- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.160(b)Required records
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 211.100(a)Approval and review of procedures
Showing 10 of 12 citations.
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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 |
| 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 |
| December 2, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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