FDA Inspection
University of Louisville Physicians OBGYN & Womens Health Fertility CenterUniversity of Louisville Physicians OBGYN & Womens Health Fertility Center – FDA Inspection, Sep 13, 2010
Record Details
This FDA Inspection record concerns University of Louisville Physicians OBGYN & Womens Health Fertility Center, with an inspection on September 13, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 13, 2010
- Product Type
- Biologics
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ID · cb37a13c-56ae-4909-b632-e8c525c69e13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 681455
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.180(a)Design adequate to bar spread of CD"s
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of University of Louisville Physicians OBGYN & Womens Health Fertility Center
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 |
Other documents for University of Louisville Physicians OBGYN & Womens Health Fertility Center
- FDA Inspection 1018102 - 2017-07-14
- FDA Inspection 904244 - 2014-11-19
- FDA Inspection 805996 - 2012-11-02
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