FDA Inspection
Aspirus Riverview Hospital and ClinicsAspirus Riverview Hospital and Clinics – FDA Inspection, Apr 27, 2012
Record Details
This FDA Inspection record concerns Aspirus Riverview Hospital and Clinics, with an inspection on April 27, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 27, 2012
- Product Type
- Biologics
View Company Profile
ID · d8f4535c-be47-4be9-8738-fc6f1c869788
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779608
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 630.40(c)Documentation
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
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 |
| June 20, 2014 | 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 883465 - 2014-06-20
- FDA Inspection 629334 - 2009-11-05
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.