FDA Inspection
Penrose-St Francis Health Services Blood BankPenrose-St Francis Health Services Blood Bank – FDA Inspection, Mar 31, 2015
Record Details
This FDA Inspection record concerns Penrose-St Francis Health Services Blood Bank, 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 · 34241f56-1596-495d-a1b3-13a3ba8f4a4b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919228
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
12- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 600.15Blood & Blood Components
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.61Obtaining consent in an appropriate manner
- 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
Showing 10 of 12 citations.
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Other FDA inspections of Penrose-St Francis Health Services Blood Bank
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 3, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 30, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Penrose-St Francis Health Services Blood Bank
- FDA Inspection 1003017 - 2017-02-24
- FDA Inspection 807683 - 2012-11-19
- FDA Inspection 712192 - 2011-03-03
- FDA Inspection 596169 - 2009-06-30
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