Brown University Health FDA Record
Brown University Health has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Brown University Health" is on file.
- Latest inspection
- Apr 20, 2026 · 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 | 7 | 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
| 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 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 20, 2026 | Providence, RI | Biologics | No Action Indicated (NAI) | 3004475081 |
| Jul 7, 2023 | Providence, RI | Biologics | No Action Indicated (NAI) | 3004475081 |
| Jan 24, 2020 | Providence, RI | Biologics | No Action Indicated (NAI) | 3004475081 |
| Jul 2, 2018 | Providence, RI | Biologics | Voluntary Action Indicated (VAI) | 3004475081 |
| May 11, 2016 | Providence, RI | Biologics | No Action Indicated (NAI) | 3004475081 |
| Nov 15, 2012 | Providence, RI | Biologics | No Action Indicated (NAI) | 3004475081 |
| Nov 10, 2010 | Providence, RI | Biologics | No Action Indicated (NAI) | 3004475081 |
- 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 3004475081 | Providence, RI | 7 | Apr 20, 2026 |
Brown University Health and the FDA: common questions
Has Brown University Health received an FDA warning letter?
No FDA warning letter addressed to the name "Brown University Health" 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 Brown University Health received an FDA Form 483?
FDA has not published a Form 483 for "Brown University Health" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Brown University Health?
The most recent FDA inspection on file ended Apr 20, 2026 at Providence, RI and was classified NAI. FDA has 7 inspections of Brown University Health on file.
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