Gago Center For Fertility FDA Record
Gago Center For Fertility has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gago Center For Fertility" is on file.
- Latest inspection
- Mar 13, 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 | 9 | 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 | 0 | 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 |
|---|---|---|---|---|
| Mar 13, 2025 | Brighton, MI | Biologics | No Action Indicated (NAI) | 3006651867 |
| Feb 28, 2023 | Brighton, MI | Biologics | No Action Indicated (NAI) | 3006651867 |
| Dec 12, 2017 | Brighton, MI | Biologics | No Action Indicated (NAI) | 3006651867 |
| Dec 22, 2015 | Brighton, MI | Biologics | No Action Indicated (NAI) | 3006651867 |
| Sep 30, 2013 | Brighton, MI | Biologics | Voluntary Action Indicated (VAI) | 3006651867 |
| Sep 30, 2013 | Lansing, MI | Biologics | Voluntary Action Indicated (VAI) | 3010418745 |
| Sep 30, 2013 | Ann Arbor, MI | Biologics | Voluntary Action Indicated (VAI) | 3010418758 |
| Dec 8, 2011 | Brighton, MI | Biologics | No Action Indicated (NAI) | 3006651867 |
| Jan 8, 2010 | Brighton, MI | Biologics | Voluntary Action Indicated (VAI) | 3006651867 |
- 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 3006651867 | Brighton, MI | 7 | Mar 13, 2025 |
| FEI 3010418745 | Lansing, MI | 1 | Sep 30, 2013 |
| FEI 3010418758 | Ann Arbor, MI | 1 | Sep 30, 2013 |
Gago Center For Fertility and the FDA: common questions
Has Gago Center For Fertility received an FDA warning letter?
No FDA warning letter addressed to the name "Gago Center For Fertility" 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 Gago Center For Fertility received an FDA Form 483?
FDA has not published a Form 483 for "Gago Center For Fertility" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Gago Center For Fertility?
The most recent FDA inspection on file ended Mar 13, 2025 at Brighton, MI and was classified NAI. FDA has 9 inspections of Gago Center For Fertility on file.
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