Cleveland Clinic Fertility Center FDA Record
- Latest inspection NAI · Apr 16, 2025
- No warning letters matched by name
Cleveland Clinic Fertility Center has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cleveland Clinic Fertility Center" is on file.
- Latest inspection
- Apr 16, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 8 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Cleveland Clinic Fertility Center: 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 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 16, 2025 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
| Sep 19, 2023 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
| Apr 1, 2022 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
| Aug 17, 2018 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
| Jun 9, 2016 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
| Feb 26, 2014 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
| Mar 21, 2012 | Beachwood, OH | Biologics | Voluntary Action Indicated (VAI) | 3003616081 |
| Dec 17, 2009 | Beachwood, OH | Biologics | No Action Indicated (NAI) | 3003616081 |
- 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 3003616081 | Beachwood, OH | 8 | Apr 16, 2025 |
Cleveland Clinic Fertility Center and the FDA: common questions
Has Cleveland Clinic Fertility Center received an FDA warning letter?
No FDA warning letter addressed to the name "Cleveland Clinic Fertility Center" 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 Cleveland Clinic Fertility Center received an FDA Form 483?
FDA has not published a Form 483 for "Cleveland Clinic Fertility Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cleveland Clinic Fertility Center?
The most recent FDA inspection on file ended Apr 16, 2025 at Beachwood, OH and was classified NAI. FDA has 8 inspections of Cleveland Clinic Fertility Center on file.
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