Boston Medical Center FDA Record
Boston Medical Center has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boston Medical Center" is on file.
- Latest inspection
- May 2, 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
| 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 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 2, 2025 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273232 |
| Sep 12, 2023 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273232 |
| May 16, 2019 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273232 |
| Mar 18, 2016 | Boston, MA | Biologics | Voluntary Action Indicated (VAI) | 1273232 |
| Feb 3, 2014 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273232 |
| Dec 27, 2011 | Boston, MA | Biologics | Voluntary Action Indicated (VAI) | 1273232 |
| May 19, 2010 | Boston, MA | Biologics | No Action Indicated (NAI) | 1273232 |
| Jan 14, 2010 | Boston, MA | Biologics | Voluntary Action Indicated (VAI) | 1273232 |
- 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 1273232 | Boston, MA | 8 | May 2, 2025 |
Boston Medical Center and the FDA: common questions
Has Boston Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Boston 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 Boston Medical Center received an FDA Form 483?
FDA has not published a Form 483 for "Boston Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Boston Medical Center?
The most recent FDA inspection on file ended May 2, 2025 at Boston, MA and was classified NAI. FDA has 8 inspections of Boston Medical Center on file.
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