Stony Brook University Hospital FDA Record
- Latest inspection NAI · May 27, 2025
- No warning letters matched by name
Stony Brook University Hospital has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Stony Brook University Hospital" is on file.
- Latest inspection
- May 27, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Stony Brook University Hospital: 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 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 27, 2025 | Stony Brook, NY | Biologics | No Action Indicated (NAI) | 2477537 |
| Mar 7, 2024 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
| Feb 7, 2023 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
| Mar 14, 2019 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
| Oct 18, 2016 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
| Sep 30, 2014 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
| Jul 18, 2012 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
| May 18, 2010 | Stony Brook, NY | Biologics | Voluntary Action Indicated (VAI) | 2477537 |
- 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 2477537 | Stony Brook, NY | 8 | May 27, 2025 |
Stony Brook University Hospital and the FDA: common questions
Has Stony Brook University Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Stony Brook University Hospital" 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 Stony Brook University Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Stony Brook University Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Stony Brook University Hospital?
The most recent FDA inspection on file ended May 27, 2025 at Stony Brook, NY and was classified NAI. FDA has 8 inspections of Stony Brook University Hospital on file.
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