FDA Inspection
Elmhurst Hospital CenterElmhurst Hospital Center – FDA Inspection, Dec 2, 2008
Record Details
This FDA Inspection record concerns Elmhurst Hospital Center, with an inspection on December 2, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Elmhurst Hospital Center
- Inspection Date
- December 2, 2008
- Product Type
- Biologics
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ID · 99ea7c7d-5ba7-4ee0-92a6-1c709df5899d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547710
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 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 |
| 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 |
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