FDA Inspection
Corewell Health Dearborn HospitalCorewell Health Dearborn Hospital – FDA Inspection, Dec 2, 2014
Record Details
This FDA Inspection record concerns Corewell Health Dearborn Hospital, with an inspection on December 2, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 2, 2014
- Product Type
- Biologics
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ID · 727cb867-d127-44af-b7ad-960c1b9ae81e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 905464
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.65(c)Testing of representative samples of reagent lots
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Corewell Health Dearborn Hospital
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 19, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 14, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 19, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 20, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Corewell Health Dearborn Hospital
- FDA Inspection 1204895 - 2023-04-27
- FDA Inspection 1061643 - 2018-07-19
- FDA Inspection 981522 - 2016-07-14
- FDA Inspection 806974 - 2012-10-19
- FDA Inspection 702515 - 2010-12-20
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