South Bend Medical Foundation, Inc. FDA Record
South Bend Medical Foundation, Inc. has 0 FDA recalls, 29 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "South Bend Medical Foundation, Inc." is on file.
- Latest inspection
- Jan 7, 2026 · VAI
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 | 29 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 3 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 7, 2026 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 3000204209 |
| Aug 1, 2025 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 1870308 |
| Feb 1, 2024 | Goshen, IN | Biologics | No Action Indicated (NAI) | 1872515 |
| Sep 1, 2023 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 1870308 |
| Aug 9, 2019 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 1870308 |
| Nov 9, 2018 | Goshen, IN | Biologics | Voluntary Action Indicated (VAI) | 1872515 |
| Nov 16, 2017 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 3000204209 |
| May 19, 2017 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 1870308 |
| Mar 29, 2017 | Indianapolis, IN | Biologics | No Action Indicated (NAI) | 3008619445 |
| Nov 22, 2016 | Goshen, IN | Biologics | No Action Indicated (NAI) | 1872515 |
| Feb 26, 2016 | South Bend, IN | Biologics | No Action Indicated (NAI) | 3000204209 |
| Jul 1, 2015 | Indianapolis, IN | Biologics | No Action Indicated (NAI) | 3008619445 |
| May 1, 2015 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 1870308 |
| Mar 17, 2015 | Goshen, IN | Biologics | No Action Indicated (NAI) | 1872515 |
| Sep 19, 2014 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 3000204209 |
| Jul 22, 2014 | Indianapolis, IN | Biologics | No Action Indicated (NAI) | 3008619445 |
| Jun 24, 2014 | Marion, IN | Biologics | No Action Indicated (NAI) | 3007701926 |
| May 10, 2013 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 1870308 |
| Apr 12, 2013 | Goshen, IN | Biologics | No Action Indicated (NAI) | 1872515 |
| Oct 26, 2012 | South Bend, IN | Biologics | Voluntary Action Indicated (VAI) | 3000204209 |
- 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 3000204209 | South Bend, IN | 7 | Jan 7, 2026 |
| FEI 1870308 | South Bend, IN | 8 | Aug 1, 2025 |
| FEI 1872515 | Goshen, IN | 7 | Feb 1, 2024 |
| FEI 3008619445 | Indianapolis, IN | 4 | Mar 29, 2017 |
| FEI 3007701926 | Marion, IN | 3 | Jun 24, 2014 |
South Bend Medical Foundation, Inc. and the FDA: common questions
Has South Bend Medical Foundation, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "South Bend Medical Foundation, Inc." 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 South Bend Medical Foundation, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "South Bend Medical Foundation, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect South Bend Medical Foundation, Inc.?
The most recent FDA inspection on file ended Jan 7, 2026 at South Bend, IN and was classified VAI. FDA has 29 inspections of South Bend Medical Foundation, Inc. on file.
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