NYU Langone Reproductive Specialists Of New York FDA Record
- Latest inspection NAI · Feb 27, 2026
- No warning letters matched by name
NYU Langone Reproductive Specialists Of New York has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "NYU Langone Reproductive Specialists Of New York" is on file.
- Latest inspection
- Feb 27, 2026 · 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 | 13 | 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 Reproductive Specialists Of New York: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 27, 2026 | Mineola, NY | Biologics | No Action Indicated (NAI) | 3003972384 |
| Mar 13, 2023 | Mineola, NY | Biologics | No Action Indicated (NAI) | 3003972384 |
| Sep 30, 2021 | Mineola, NY | Biologics | No Action Indicated (NAI) | 3003972384 |
| Sep 25, 2020 | Mineola, NY | Biologics | Voluntary Action Indicated (VAI) | 3003972384 |
| Oct 31, 2017 | Stony Brook, NY | Biologics | No Action Indicated (NAI) | 3008927105 |
| Oct 27, 2017 | Mineola, NY | Biologics | Voluntary Action Indicated (VAI) | 3003972384 |
| Dec 21, 2015 | Stony Brook, NY | Biologics | No Action Indicated (NAI) | 3008927105 |
| Oct 16, 2015 | Mineola, NY | Biologics | Voluntary Action Indicated (VAI) | 3003972384 |
| Dec 12, 2013 | Stony Brook, NY | Biologics | No Action Indicated (NAI) | 3008927105 |
| Nov 6, 2013 | Mineola, NY | Biologics | No Action Indicated (NAI) | 3003972384 |
| Jan 25, 2012 | Stony Brook, NY | Biologics | No Action Indicated (NAI) | 3008927105 |
| Dec 15, 2011 | Mineola, NY | Biologics | Voluntary Action Indicated (VAI) | 3003972384 |
| Apr 21, 2009 | Mineola, NY | Biologics | Voluntary Action Indicated (VAI) | 3003972384 |
- 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 3003972384 | Mineola, NY | 9 | Feb 27, 2026 |
| FEI 3008927105 | Stony Brook, NY | 4 | Oct 31, 2017 |
NYU Langone Reproductive Specialists Of New York and the FDA: common questions
Has NYU Langone Reproductive Specialists Of New York received an FDA warning letter?
No FDA warning letter addressed to the name "NYU Langone Reproductive Specialists Of New York" 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 Reproductive Specialists Of New York received an FDA Form 483?
FDA has not published a Form 483 for "NYU Langone Reproductive Specialists Of New York" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect NYU Langone Reproductive Specialists Of New York?
The most recent FDA inspection on file ended Feb 27, 2026 at Mineola, NY and was classified NAI. FDA has 13 inspections of NYU Langone Reproductive Specialists Of New York on file.
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