Beth Israel Deaconess Medical Center IRB FDA Record
- Latest inspection NAI · May 8, 2024
- No warning letters matched by name
Beth Israel Deaconess Medical Center IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Beth Israel Deaconess Medical Center IRB" is on file.
- Latest inspection
- May 8, 2024 · 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, refresh in progress |
| Inspections | 4 | 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
Beth Israel Deaconess Medical Center IRB: 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 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 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 |
|---|---|---|---|---|
| May 8, 2024 | Boston, MA | Biologics | No Action Indicated (NAI) | 1219208 |
| May 25, 2017 | Boston, MA | Drugs | No Action Indicated (NAI) | 1219208 |
| Sep 20, 2012 | Boston, MA | Devices | No Action Indicated (NAI) | 1219208 |
| Sep 24, 2009 | Boston, MA | Devices | No Action Indicated (NAI) | 1219208 |
- 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 1219208 | Boston, MA | 4 | May 8, 2024 |
Beth Israel Deaconess Medical Center IRB and the FDA: common questions
Has Beth Israel Deaconess Medical Center IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Beth Israel Deaconess Medical Center IRB" 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 Beth Israel Deaconess Medical Center IRB received an FDA Form 483?
FDA has not published a Form 483 for "Beth Israel Deaconess Medical Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Beth Israel Deaconess Medical Center IRB?
The most recent FDA inspection on file ended May 8, 2024 at Boston, MA and was classified NAI. FDA has 4 inspections of Beth Israel Deaconess Medical Center IRB on file.
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