Indiana Fertility Institute LLC FDA Record
- Latest inspection NAI · Aug 12, 2025
- No warning letters matched by name
Indiana Fertility Institute LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Indiana Fertility Institute LLC" is on file.
- Latest inspection
- Aug 12, 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
Indiana Fertility Institute LLC: 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 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|---|
| Aug 12, 2025 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005863342 |
| Jan 7, 2020 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005863342 |
| Jun 28, 2017 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005863342 |
| Nov 24, 2015 | Carmel, IN | Biologics | Voluntary Action Indicated (VAI) | 3005863342 |
| Jul 9, 2013 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005863342 |
| Aug 29, 2011 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005863342 |
| Sep 15, 2009 | Carmel, IN | Biologics | No Action Indicated (NAI) | 3005863342 |
- 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 3005863342 | Carmel, IN | 7 | Aug 12, 2025 |
Indiana Fertility Institute LLC and the FDA: common questions
Has Indiana Fertility Institute LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Indiana Fertility Institute LLC" 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 Indiana Fertility Institute LLC received an FDA Form 483?
FDA has not published a Form 483 for "Indiana Fertility Institute LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Indiana Fertility Institute LLC?
The most recent FDA inspection on file ended Aug 12, 2025 at Carmel, IN and was classified NAI. FDA has 7 inspections of Indiana Fertility Institute LLC on file.
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