Fertility Laboratories Of Colorado, LLC FDA Record
- Latest inspection NAI · Jul 14, 2025
- No warning letters matched by name
Fertility Laboratories Of Colorado, LLC has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fertility Laboratories Of Colorado, LLC" is on file.
- Latest inspection
- Jul 14, 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 | 4 | 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
Fertility Laboratories Of Colorado, 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 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|---|
| Jul 14, 2025 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3005811913 |
| Dec 10, 2019 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3005811913 |
| Apr 11, 2017 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3005811913 |
| Nov 1, 2012 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3005811913 |
- 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 3005811913 | Lone Tree, CO | 4 | Jul 14, 2025 |
Fertility Laboratories Of Colorado, LLC and the FDA: common questions
Has Fertility Laboratories Of Colorado, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Fertility Laboratories Of Colorado, 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 Fertility Laboratories Of Colorado, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Fertility Laboratories Of Colorado, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Fertility Laboratories Of Colorado, LLC?
The most recent FDA inspection on file ended Jul 14, 2025 at Lone Tree, CO and was classified NAI. FDA has 4 inspections of Fertility Laboratories Of Colorado, LLC on file.
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