OU Health Reproductive Medicine Lab FDA Record
- Latest inspection NAI · Jun 10, 2025
- No warning letters matched by name
OU Health Reproductive Medicine Lab has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "OU Health Reproductive Medicine Lab" is on file.
- Latest inspection
- Jun 10, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 5 | 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
OU Health Reproductive Medicine Lab: 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 | 1 | 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 |
|---|---|---|---|---|
| Jun 10, 2025 | Oklahoma City, OK | Biologics | No Action Indicated (NAI) | 3004961294 |
| Apr 18, 2022 | Oklahoma City, OK | Biologics | No Action Indicated (NAI) | 3004961294 |
| Jun 21, 2017 | Oklahoma City, OK | Biologics | Voluntary Action Indicated (VAI) | 3004961294 |
| Mar 28, 2013 | Oklahoma City, OK | Biologics | No Action Indicated (NAI) | 3004961294 |
| Nov 16, 2010 | Oklahoma City, OK | Biologics | No Action Indicated (NAI) | 3004961294 |
- 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 3004961294 | Oklahoma City, OK | 5 | Jun 10, 2025 |
OU Health Reproductive Medicine Lab and the FDA: common questions
Has OU Health Reproductive Medicine Lab received an FDA warning letter?
No FDA warning letter addressed to the name "OU Health Reproductive Medicine Lab" 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 OU Health Reproductive Medicine Lab received an FDA Form 483?
FDA has not published a Form 483 for "OU Health Reproductive Medicine Lab" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect OU Health Reproductive Medicine Lab?
The most recent FDA inspection on file ended Jun 10, 2025 at Oklahoma City, OK and was classified NAI. FDA has 5 inspections of OU Health Reproductive Medicine Lab on file.
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