Sanford Medical Center FDA Record
- Latest inspection NAI · Jun 18, 2026
- No warning letters matched by name
Sanford Medical Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sanford Medical Center" is on file.
- Latest inspection
- Jun 18, 2026 · 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 | 7 | 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
Sanford Medical Center: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 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 |
|---|---|---|---|---|
| Jun 18, 2026 | Sioux Falls, SD | Biologics | No Action Indicated (NAI) | 3031879326 |
| Oct 27, 2023 | Sioux Falls, SD | Biologics | No Action Indicated (NAI) | 1771187 |
| Sep 6, 2018 | Sioux Falls, SD | Biologics | No Action Indicated (NAI) | 1771187 |
| Mar 31, 2015 | Sioux Falls, SD | Biologics | No Action Indicated (NAI) | 1771187 |
| Jun 20, 2013 | Sioux Falls, SD | Biologics | No Action Indicated (NAI) | 1771187 |
| May 17, 2011 | Sioux Falls, SD | Biologics | No Action Indicated (NAI) | 1771187 |
| Mar 26, 2010 | Sioux Falls, SD | Biologics | Voluntary Action Indicated (VAI) | 1771187 |
- 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 3031879326 | Sioux Falls, SD | 1 | Jun 18, 2026 |
| FEI 1771187 | Sioux Falls, SD | 6 | Oct 27, 2023 |
Sanford Medical Center and the FDA: common questions
Has Sanford Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Sanford Medical Center" 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 Sanford Medical Center received an FDA Form 483?
FDA has not published a Form 483 for "Sanford Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sanford Medical Center?
The most recent FDA inspection on file ended Jun 18, 2026 at Sioux Falls, SD and was classified NAI. FDA has 7 inspections of Sanford Medical Center on file.
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