Midwest Fertility Specialists FDA Record
Midwest Fertility Specialists has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Midwest Fertility Specialists" is on file. FDA has published 1 Form 483 for Midwest Fertility Specialists.
- Latest inspection
- Nov 25, 2024 · VAI
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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 | 10 | 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 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
Midwest Fertility Specialists Form 483s
| Date | Document | FEI |
|---|---|---|
| Nov 25, 2024 | 483 | 3005620323 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 25, 2024 | Carmel, IN | Biologics | Voluntary Action Indicated (VAI) | 3005620323 |
| Mar 22, 2022 | Fort Wayne, IN | Biologics | No Action Indicated (NAI) | 3005620268 |
| Oct 16, 2019 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005620323 |
| Aug 1, 2017 | Fort Wayne, IN | Biologics | No Action Indicated (NAI) | 3005620268 |
| Jun 21, 2017 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005620323 |
| Jun 18, 2015 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005620323 |
| Mar 25, 2015 | Fort Wayne, IN | Biologics | No Action Indicated (NAI) | 3005620268 |
| Jan 31, 2013 | Carmel, IN | Biologics | Voluntary Action Indicated (VAI) | 3005620323 |
| Nov 6, 2012 | Fort Wayne, IN | Biologics | No Action Indicated (NAI) | 3005620268 |
| Apr 19, 2010 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005620323 |
- 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 3005620323 | Carmel, IN | 6 | Nov 25, 2024 |
| FEI 3005620268 | Fort Wayne, IN | 4 | Mar 22, 2022 |
Midwest Fertility Specialists and the FDA: common questions
Has Midwest Fertility Specialists received an FDA warning letter?
No FDA warning letter addressed to the name "Midwest Fertility Specialists" 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 Midwest Fertility Specialists received an FDA Form 483?
FDA has published 1 Form 483 for Midwest Fertility Specialists in its reading room, the most recent dated Nov 25, 2024. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Midwest Fertility Specialists?
The most recent FDA inspection on file ended Nov 25, 2024 at Carmel, IN and was classified VAI. FDA has 10 inspections of Midwest Fertility Specialists on file.
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