FDA Inspection
Montefiore's Institute for Reproductive Medicine and HealthMontefiore's Institute for Reproductive Medicine and Health – FDA Inspection, May 3, 2019
Record Details
This FDA Inspection record concerns Montefiore's Institute for Reproductive Medicine and Health, with an inspection on May 3, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 3, 2019
- Product Type
- Biologics
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ID · e3216f4e-2731-4074-ae33-6b2bb31e10b1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1088610
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
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 |
| March 22, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 10, 2015 | VAI | 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 1008038 - 2017-03-22
- FDA Inspection 938861 - 2015-08-10
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