FDA Inspection
Aspirus Riverview Hospital and ClinicsAspirus Riverview Hospital and Clinics – FDA Inspection, Jun 20, 2014
Record Details
This FDA Inspection record concerns Aspirus Riverview Hospital and Clinics, with an inspection on June 20, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 20, 2014
- Product Type
- Biologics
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ID · 5d8c4b29-1aa0-41c2-9da0-da9ef6b653e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883465
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Aspirus Riverview Hospital and Clinics
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 27, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 5, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Aspirus Riverview Hospital and Clinics
- FDA Inspection 961415 - 2016-01-14
- FDA Inspection 779608 - 2012-04-27
- FDA Inspection 629334 - 2009-11-05
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