FDA Inspection
Penrose-St Francis Health ServicesPenrose-St Francis Health Services – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Penrose-St Francis Health Services, with an inspection on December 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 6, 2012
- Product Type
- Biologics
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ID · 46507ccd-09c7-402a-91eb-76d8d3059f9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807682
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| March 31, 2015 | 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 919227 - 2015-03-31
- FDA Inspection 715754 - 2011-03-03
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