FDA Inspection
Bonfils Blood Center at Exempla Saint Joseph HospitalBonfils Blood Center at Exempla Saint Joseph Hospital – FDA Inspection, Oct 3, 2012
Record Details
This FDA Inspection record concerns Bonfils Blood Center at Exempla Saint Joseph Hospital, with an inspection on October 3, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 3, 2012
- Product Type
- Biologics
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ID · 79f2d37b-48e6-4d5f-a5de-e6844f0f6d2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802162
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Bonfils Blood Center at Exempla Saint Joseph Hospital
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 11, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bonfils Blood Center at Exempla Saint Joseph Hospital
- FDA Inspection 859561 - 2013-12-17
- FDA Inspection 786013 - 2012-06-11
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