Thomas Jefferson University Institutional Review Board FDA Record
- Latest inspection NAI · Dec 7, 2022
- Last warning letter 2019
Thomas Jefferson University Institutional Review Board has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Thomas Jefferson University Institutional Review Board, the most recent on Jun 24, 2019.
- Latest inspection
- Dec 7, 2022 · 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 | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Thomas Jefferson University Institutional Review Board: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 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 | 1 | 1 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Thomas Jefferson University Institutional Review Board FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 24, 2019 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 7, 2022 | Philadelphia, PA | Biologics | No Action Indicated (NAI) | 2523696 |
| Feb 15, 2019 | Philadelphia, PA | Biologics | Official Action Indicated (OAI) | 2523696 |
| Jun 28, 2018 | Philadelphia, PA | Drugs | No Action Indicated (NAI) | 2523696 |
| Jun 18, 2015 | Philadelphia, PA | Devices | Official Action Indicated (OAI) | 2523696 |
| Mar 27, 2014 | Philadelphia, PA | Devices | No Action Indicated (NAI) | 2523696 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Thomas Jefferson University Institutional Review Board: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2523696 | Philadelphia, PA | 5 | Dec 7, 2022 |
Thomas Jefferson University Institutional Review Board and the FDA: common questions
Has Thomas Jefferson University Institutional Review Board received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Thomas Jefferson University Institutional Review Board. The most recent is dated Jun 24, 2019.
Has Thomas Jefferson University Institutional Review Board received an FDA Form 483?
FDA has not published a Form 483 for "Thomas Jefferson University Institutional Review Board" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Thomas Jefferson University Institutional Review Board?
The most recent FDA inspection on file ended Dec 7, 2022 at Philadelphia, PA and was classified NAI. FDA has 5 inspections of Thomas Jefferson University Institutional Review Board on file, 2 of them classified OAI (official action indicated).
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