UF Health Shands Medical Laboratories Blood Bank FDA Record
- Latest inspection NAI · Aug 18, 2025
- No warning letters matched by name
UF Health Shands Medical Laboratories Blood Bank has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "UF Health Shands Medical Laboratories Blood Bank" is on file.
- Latest inspection
- Aug 18, 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 | 7 | 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
UF Health Shands Medical Laboratories Blood Bank: 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 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 18, 2025 | Gainesville, FL | Biologics | No Action Indicated (NAI) | 1073823 |
| Apr 5, 2023 | Gainesville, FL | Biologics | No Action Indicated (NAI) | 1073823 |
| Jan 25, 2018 | Gainesville, FL | Biologics | Voluntary Action Indicated (VAI) | 1073823 |
| Feb 25, 2016 | Gainesville, FL | Biologics | Voluntary Action Indicated (VAI) | 1073823 |
| Jul 23, 2014 | Gainesville, FL | Biologics | No Action Indicated (NAI) | 1073823 |
| Sep 11, 2012 | Gainesville, FL | Biologics | No Action Indicated (NAI) | 1073823 |
| Jun 1, 2010 | Gainesville, FL | Biologics | No Action Indicated (NAI) | 1073823 |
- 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 1073823 | Gainesville, FL | 7 | Aug 18, 2025 |
UF Health Shands Medical Laboratories Blood Bank and the FDA: common questions
Has UF Health Shands Medical Laboratories Blood Bank received an FDA warning letter?
No FDA warning letter addressed to the name "UF Health Shands Medical Laboratories Blood Bank" 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 UF Health Shands Medical Laboratories Blood Bank received an FDA Form 483?
FDA has not published a Form 483 for "UF Health Shands Medical Laboratories Blood Bank" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect UF Health Shands Medical Laboratories Blood Bank?
The most recent FDA inspection on file ended Aug 18, 2025 at Gainesville, FL and was classified NAI. FDA has 7 inspections of UF Health Shands Medical Laboratories Blood Bank on file.
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