Emerson Health Hospital FDA Record
- Latest inspection VAI · Aug 6, 2025
- No warning letters matched by name
Emerson Health Hospital has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Emerson Health Hospital" is on file.
- Latest inspection
- Aug 6, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 10 | 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
Emerson Health Hospital: 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 |
|---|---|---|---|---|
| Aug 6, 2025 | Concord, MA | Biologics | Voluntary Action Indicated (VAI) | 1274643 |
| Mar 30, 2023 | Concord, MA | Biologics | No Action Indicated (NAI) | 1274643 |
| Feb 4, 2019 | Concord, MA | Biologics | Voluntary Action Indicated (VAI) | 1274643 |
| Apr 13, 2017 | Concord, MA | Biologics | No Action Indicated (NAI) | 1274643 |
| Jan 13, 2015 | Concord, MA | Biologics | Voluntary Action Indicated (VAI) | 1274643 |
| Mar 13, 2013 | Concord, MA | Biologics | No Action Indicated (NAI) | 1274643 |
| Jun 1, 2012 | Concord, MA | Biologics | No Action Indicated (NAI) | 1274643 |
| Nov 18, 2011 | Concord, MA | Biologics | No Action Indicated (NAI) | 1274643 |
| Jul 19, 2010 | Concord, MA | Biologics | Voluntary Action Indicated (VAI) | 1274643 |
| Nov 3, 2008 | Concord, MA | Biologics | No Action Indicated (NAI) | 1274643 |
- 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 1274643 | Concord, MA | 10 | Aug 6, 2025 |
Emerson Health Hospital and the FDA: common questions
Has Emerson Health Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Emerson Health Hospital" 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 Emerson Health Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Emerson Health Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Emerson Health Hospital?
The most recent FDA inspection on file ended Aug 6, 2025 at Concord, MA and was classified VAI. FDA has 10 inspections of Emerson Health Hospital on file.
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