CNY Fertility Colorado PLLC FDA Record
CNY Fertility Colorado PLLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CNY Fertility Colorado PLLC" is on file.
- Latest inspection
- May 16, 2024 · 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 | 6 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 16, 2024 | Colorado Springs, CO | Biologics | No Action Indicated (NAI) | 3004590904 |
| Feb 7, 2019 | Colorado Springs, CO | Biologics | No Action Indicated (NAI) | 3004590904 |
| Jan 26, 2016 | Colorado Springs, CO | Biologics | Voluntary Action Indicated (VAI) | 3004590904 |
| Apr 24, 2013 | Colorado Springs, CO | Biologics | Voluntary Action Indicated (VAI) | 3004590904 |
| Dec 13, 2010 | Colorado Springs, CO | Biologics | No Action Indicated (NAI) | 3004590904 |
| Sep 16, 2009 | Colorado Springs, CO | Biologics | Voluntary Action Indicated (VAI) | 3004590904 |
- 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 3004590904 | Colorado Springs, CO | 6 | May 16, 2024 |
CNY Fertility Colorado PLLC and the FDA: common questions
Has CNY Fertility Colorado PLLC received an FDA warning letter?
No FDA warning letter addressed to the name "CNY Fertility Colorado PLLC" 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 CNY Fertility Colorado PLLC received an FDA Form 483?
FDA has not published a Form 483 for "CNY Fertility Colorado PLLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CNY Fertility Colorado PLLC?
The most recent FDA inspection on file ended May 16, 2024 at Colorado Springs, CO and was classified NAI. FDA has 6 inspections of CNY Fertility Colorado PLLC on file.
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