Bluegrass Fertility Center FDA Record
Bluegrass Fertility Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bluegrass Fertility Center" is on file.
- Latest inspection
- Mar 19, 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 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 19, 2025 | Lexington, KY | Biologics | No Action Indicated (NAI) | 3004557185 |
| May 24, 2023 | Lexington, KY | Biologics | No Action Indicated (NAI) | 3004557185 |
| Feb 12, 2020 | Lexington, KY | Biologics | No Action Indicated (NAI) | 3004557185 |
| Jan 17, 2018 | Lexington, KY | Biologics | No Action Indicated (NAI) | 3004557185 |
| Nov 10, 2014 | Lexington, KY | Biologics | Voluntary Action Indicated (VAI) | 3004557185 |
| Aug 29, 2012 | Lexington, KY | Biologics | No Action Indicated (NAI) | 3004557185 |
| Jun 9, 2010 | Lexington, KY | Biologics | No Action Indicated (NAI) | 3004557185 |
- 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 3004557185 | Lexington, KY | 7 | Mar 19, 2025 |
Bluegrass Fertility Center and the FDA: common questions
Has Bluegrass Fertility Center received an FDA warning letter?
No FDA warning letter addressed to the name "Bluegrass 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 Bluegrass Fertility Center received an FDA Form 483?
FDA has not published a Form 483 for "Bluegrass Fertility Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bluegrass Fertility Center?
The most recent FDA inspection on file ended Mar 19, 2025 at Lexington, KY and was classified NAI. FDA has 7 inspections of Bluegrass Fertility Center on file.
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