Colorado Center For Reproductive Medicine FDA Record
- Latest inspection NAI · Jul 14, 2025
- No warning letters matched by name
Colorado Center For Reproductive Medicine has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Colorado Center For Reproductive Medicine" 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, refresh in progress |
| 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
Colorado Center For Reproductive Medicine: 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 |
|---|---|---|---|---|
| Jul 14, 2025 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3004553569 |
| Aug 20, 2020 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3004553569 |
| Apr 7, 2017 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3004553569 |
| Nov 1, 2012 | Lone Tree, CO | Biologics | No Action Indicated (NAI) | 3004553569 |
- 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 3004553569 | Lone Tree, CO | 4 | Jul 14, 2025 |
Colorado Center For Reproductive Medicine and the FDA: common questions
Has Colorado Center For Reproductive Medicine received an FDA warning letter?
No FDA warning letter addressed to the name "Colorado Center For Reproductive Medicine" 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 Colorado Center For Reproductive Medicine received an FDA Form 483?
FDA has not published a Form 483 for "Colorado Center For Reproductive Medicine" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Colorado Center For Reproductive Medicine?
The most recent FDA inspection on file ended Jul 14, 2025 at Lone Tree, CO and was classified NAI. FDA has 4 inspections of Colorado Center For Reproductive Medicine on file.
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