FDA Inspection
Louisville Reproductive CenterLouisville Reproductive Center – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Louisville Reproductive Center, with an inspection on June 15, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f22a3592-b4fd-42f3-b583-f2f9734fab50
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1014448
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.75(e)Abbreviated procedure
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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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