Henry Ford St John Hospital FDA Record
Henry Ford St John Hospital has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Henry Ford St John Hospital" is on file.
- Latest inspection
- Jul 10, 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 | 7 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|---|
| Jul 10, 2025 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
| Oct 13, 2022 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
| Nov 29, 2017 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
| Dec 9, 2015 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
| Dec 26, 2013 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
| Dec 22, 2011 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
| Jul 14, 2009 | Detroit, MI | Biologics | No Action Indicated (NAI) | 1870553 |
- 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 1870553 | Detroit, MI | 7 | Jul 10, 2025 |
Henry Ford St John Hospital and the FDA: common questions
Has Henry Ford St John Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Henry Ford St John 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 St John Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Henry Ford St John Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Henry Ford St John Hospital?
The most recent FDA inspection on file ended Jul 10, 2025 at Detroit, MI and was classified NAI. FDA has 7 inspections of Henry Ford St John Hospital on file.
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