FDA Inspection
Penrose-St Francis Health Services Blood BankPenrose-St Francis Health Services Blood Bank – FDA Inspection, Jun 30, 2009
Record Details
This FDA Inspection record concerns Penrose-St Francis Health Services Blood Bank, with an inspection on June 30, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 30, 2009
- Product Type
- Biologics
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ID · 4d5f1921-1324-432d-9eb9-93eb8505783f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596169
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| March 31, 2015 | 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 |
Other documents for Penrose-St Francis Health Services Blood Bank
- FDA Inspection 1003017 - 2017-02-24
- FDA Inspection 919228 - 2015-03-31
- FDA Inspection 807683 - 2012-11-19
- FDA Inspection 712192 - 2011-03-03
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