Beth Israel Deaconess Medical Center FDA Record
- Latest inspection NAI · Apr 30, 2025
- No warning letters matched by name
Beth Israel Deaconess Medical Center has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Beth Israel Deaconess Medical Center" is on file.
- Latest inspection
- Apr 30, 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 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: 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 | 0 | 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 30, 2025 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273763 |
| Sep 11, 2023 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273763 |
| Jun 10, 2019 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273763 |
| Apr 19, 2017 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273763 |
| Feb 13, 2015 | Boston, MA | Devices | No Action Indicated (NAI) | 1273763 |
| Jun 19, 2013 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273763 |
| Jul 12, 2012 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273763 |
| Oct 26, 2010 | Boston, MA | Biologics | Voluntary Action Indicated (VAI) | 1273763 |
- 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 1273763 | Boston, MA | 8 | Apr 30, 2025 |
Beth Israel Deaconess Medical Center and the FDA: common questions
Has Beth Israel Deaconess Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Beth Israel Deaconess Medical Center" 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 received an FDA Form 483?
FDA has not published a Form 483 for "Beth Israel Deaconess Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Beth Israel Deaconess Medical Center?
The most recent FDA inspection on file ended Apr 30, 2025 at Boston, MA and was classified NAI. FDA has 8 inspections of Beth Israel Deaconess Medical Center on file.
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