NYU Langone Health, Transplantation & Cellular Therapy FDA Record
- Latest inspection NAI · Jun 27, 2025
- No warning letters matched by name
NYU Langone Health, Transplantation & Cellular Therapy has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "NYU Langone Health, Transplantation & Cellular Therapy" is on file.
- Latest inspection
- Jun 27, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 9 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
NYU Langone Health, Transplantation & Cellular Therapy: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 27, 2025 | New York, NY | Biologics | No Action Indicated (NAI) | 2470026 |
| Sep 26, 2024 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
| Aug 19, 2022 | New York, NY | Biologics | No Action Indicated (NAI) | 2470026 |
| May 18, 2017 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
| Apr 9, 2015 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
| Mar 25, 2013 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
| Jun 21, 2011 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
| Dec 31, 2008 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
| Dec 19, 2008 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 2470026 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2470026 | New York, NY | 9 | Jun 27, 2025 |
NYU Langone Health, Transplantation & Cellular Therapy and the FDA: common questions
Has NYU Langone Health, Transplantation & Cellular Therapy received an FDA warning letter?
No FDA warning letter addressed to the name "NYU Langone Health, Transplantation & Cellular Therapy" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has NYU Langone Health, Transplantation & Cellular Therapy received an FDA Form 483?
FDA has not published a Form 483 for "NYU Langone Health, Transplantation & Cellular Therapy" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect NYU Langone Health, Transplantation & Cellular Therapy?
The most recent FDA inspection on file ended Jun 27, 2025 at New York, NY and was classified NAI. FDA has 9 inspections of NYU Langone Health, Transplantation & Cellular Therapy on file.
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