UC San Diego Health Andrology Laboratory FDA Record
- Latest inspection NAI · Jun 10, 2025
- No warning letters matched by name
UC San Diego Health Andrology Laboratory has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "UC San Diego Health Andrology Laboratory" 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 | 2 | 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
UC San Diego Health Andrology Laboratory: 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 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 10, 2025 | San Diego, CA | Biologics | No Action Indicated (NAI) | 3017399128 |
| Jul 20, 2022 | San Diego, CA | Biologics | No Action Indicated (NAI) | 3017399128 |
- 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 3017399128 | San Diego, CA | 2 | Jun 10, 2025 |
UC San Diego Health Andrology Laboratory and the FDA: common questions
Has UC San Diego Health Andrology Laboratory received an FDA warning letter?
No FDA warning letter addressed to the name "UC San Diego Health Andrology Laboratory" 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 UC San Diego Health Andrology Laboratory received an FDA Form 483?
FDA has not published a Form 483 for "UC San Diego Health Andrology Laboratory" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect UC San Diego Health Andrology Laboratory?
The most recent FDA inspection on file ended Jun 10, 2025 at San Diego, CA and was classified NAI. FDA has 2 inspections of UC San Diego Health Andrology Laboratory on file.
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