FDA Inspection
Montefiore's Institute for Reproductive Medicine and HealthMontefiore's Institute for Reproductive Medicine and Health – FDA Inspection, Aug 10, 2015
Record Details
This FDA Inspection record concerns Montefiore's Institute for Reproductive Medicine and Health, with an inspection on August 10, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 10, 2015
- Product Type
- Biologics
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ID · e61a2b36-f385-45f3-b69f-00aa02dc0eed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938861
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.65(b)(2)Prominently labeled (limited use)
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Montefiore's Institute for Reproductive Medicine and Health
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2026 | Not classified | New York District Office | |
| August 16, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 16, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 3, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 22, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Montefiore's Institute for Reproductive Medicine and Health
- FDA Inspection 1327662 - 2026-06-24
- FDA Inspection 1215614 - 2023-08-16
- FDA Inspection 1148967 - 2021-08-16
- FDA Inspection 1088610 - 2019-05-03
- FDA Inspection 1008038 - 2017-03-22
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