FDA Inspection
Penrose-St Francis Health Services Blood BankPenrose-St Francis Health Services Blood Bank – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Penrose-St Francis Health Services Blood Bank, with an inspection on February 24, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 24, 2017
- Product Type
- Biologics
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ID · 5119423b-0bf0-4a71-a28b-dd517ca3a706
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003017
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 630.30(a)(3)Donor medical history
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 630.30(b)(1)Unsuitable donation - release
- 21 CFR 640.4(f)Arm preparation
- 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 |
|---|---|---|---|
| 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 |
| 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 919228 - 2015-03-31
- FDA Inspection 807683 - 2012-11-19
- FDA Inspection 712192 - 2011-03-03
- FDA Inspection 596169 - 2009-06-30
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