Henry Ford Hospital FDA Record
Henry Ford Hospital has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Henry Ford Hospital" is on file.
- Latest inspection
- May 31, 2023 · NAI
- Latest 510(k)
- Apr 10, 1981
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | 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 | 0 | 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 |
|---|---|---|---|---|
| May 31, 2023 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1876141 |
| Jul 19, 2019 | Detroit, MI | Biologics | Voluntary Action Indicated (VAI) | 1876141 |
| Jan 11, 2017 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1876141 |
| Feb 20, 2015 | Detroit, MI | Biologics | Voluntary Action Indicated (VAI) | 1876141 |
| Dec 7, 2012 | Detroit, MI | Biologics | Voluntary Action Indicated (VAI) | 1876141 |
| Aug 11, 2010 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1876141 |
- 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 1876141 | Detroit, MI | 6 | May 31, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K810828 | NON-INVASIVE AMPLIFIER | Apr 10, 1981 |
Henry Ford Hospital and the FDA: common questions
Has Henry Ford Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Henry Ford 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 Henry Ford Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Henry Ford Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Henry Ford Hospital?
The most recent FDA inspection on file ended May 31, 2023 at Detroit, MI and was classified NAI. FDA has 6 inspections of Henry Ford Hospital on file.
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