FDA Inspection
Elmhurst Hospital CenterElmhurst Hospital Center – FDA Inspection, Sep 21, 2012
Record Details
This FDA Inspection record concerns Elmhurst Hospital Center, with an inspection on September 21, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Elmhurst Hospital Center
- Inspection Date
- September 21, 2012
- Product Type
- Biologics
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ID · 9a96ce68-ea34-44c9-935b-7c112041c38e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799711
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)(1)Donor criteria
- 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 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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