FDA Inspection
Louisville Reproductive CenterLouisville Reproductive Center – FDA Inspection, May 6, 2013
Record Details
This FDA Inspection record concerns Louisville Reproductive Center, with an inspection on May 6, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 6, 2013
- Product Type
- Biologics
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ID · bc2a3216-2e9b-4681-aff4-ce96ddfe0df4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831058
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
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Other FDA inspections of Louisville Reproductive Center
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2025 | OAI | Cincinnati District Office | Human Cellular, Tissue, and Gene Therapies |
| August 22, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 14, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 8, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| January 4, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Louisville Reproductive Center
- FDA Inspection 1268429 - 2025-04-28
- FDA Inspection 1215469 - 2023-08-22
- FDA Inspection 1172027 - 2022-06-14
- FDA Inspection 1139891 - 2021-04-08
- FDA Inspection 1037302 - 2018-01-04
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