FDA Inspection
Penrose-St Francis Health ServicesPenrose-St Francis Health Services – FDA Inspection, Mar 31, 2015
Record Details
This FDA Inspection record concerns Penrose-St Francis Health Services, with an inspection on March 31, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 31, 2015
- Product Type
- Biologics
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ID · 62bce239-1c95-4905-b2fd-c2ad69fd4d7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919227
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.150(b)Distribution Recall System
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Other FDA inspections of Penrose-St Francis Health Services
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 21, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 6, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Penrose-St Francis Health Services
- FDA Inspection 1084849 - 2019-02-05
- FDA Inspection 1002033 - 2017-02-21
- FDA Inspection 807682 - 2012-12-06
- FDA Inspection 715754 - 2011-03-03
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