FDA Inspection
University of Louisville Physicians OBGYN & Womens Health Fertility CenterUniversity of Louisville Physicians OBGYN & Womens Health Fertility Center – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns University of Louisville Physicians OBGYN & Womens Health Fertility Center, with an inspection on July 14, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 14, 2017
- Product Type
- Biologics
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ID · 3889ef14-1204-4d12-8590-58dbb64a7d3d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1018102
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
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Other FDA inspections of University of Louisville Physicians OBGYN & Womens Health Fertility Center
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 2, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 13, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for University of Louisville Physicians OBGYN & Womens Health Fertility Center
- FDA Inspection 904244 - 2014-11-19
- FDA Inspection 805996 - 2012-11-02
- FDA Inspection 681455 - 2010-09-13
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