FDA Inspection
NYU Langone Reproductive Specialists of New YorkNYU Langone Reproductive Specialists of New York – FDA Inspection, Oct 16, 2015
Record Details
This FDA Inspection record concerns NYU Langone Reproductive Specialists of New York, with an inspection on October 16, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 16, 2015
- Product Type
- Biologics
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ID · 7e19d70f-e447-4503-99f2-17ff0c7ae9c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947868
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NYU Langone Reproductive Specialists of New York
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2026 | Not classified | New York District Office | |
| March 13, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 30, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 25, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 27, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for NYU Langone Reproductive Specialists of New York
- FDA Inspection 1304730 - 2026-02-27
- FDA Inspection 1199834 - 2023-03-13
- FDA Inspection 1153269 - 2021-09-30
- FDA Inspection 1129967 - 2020-09-25
- FDA Inspection 1030012 - 2017-10-27
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