FDA Inspection
Institute for Reproductive HealthInstitute for Reproductive Health – FDA Inspection, Aug 30, 2023
Record Details
This FDA Inspection record concerns Institute for Reproductive Health, with an inspection on August 30, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d852e441-f957-4f83-be82-bcbfed8a5eb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216366
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Institute for Reproductive Health
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 15, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 14, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 23, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 25, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Institute for Reproductive Health
- FDA Inspection 1296650 - 2025-12-17
- FDA Inspection 1269958 - 2025-05-15
- FDA Inspection 1146177 - 2021-07-14
- FDA Inspection 1053319 - 2018-05-23
- FDA Inspection 971871 - 2016-05-25
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