South Dakota Lions Eye And Tissue Bank Inc FDA Record
- Latest inspection NAI · May 30, 2024
- No warning letters matched by name
South Dakota Lions Eye And Tissue Bank Inc has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "South Dakota Lions Eye And Tissue Bank Inc" is on file.
- Latest inspection
- May 30, 2024 · 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 | 11 | 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
South Dakota Lions Eye And Tissue Bank Inc: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 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 | 2 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 30, 2024 | Fargo, ND | Biologics | No Action Indicated (NAI) | 3012792221 |
| May 28, 2024 | Bismarck, ND | Biologics | No Action Indicated (NAI) | 3011394216 |
| Apr 14, 2022 | Rapid City, SD | Biologics | No Action Indicated (NAI) | 3006850594 |
| Nov 21, 2019 | Bismarck, ND | Biologics | No Action Indicated (NAI) | 3011394216 |
| Nov 15, 2019 | Fargo, ND | Biologics | No Action Indicated (NAI) | 3012792221 |
| Mar 20, 2018 | Bismarck, ND | Biologics | No Action Indicated (NAI) | 3011394216 |
| Mar 9, 2018 | Fargo, ND | Biologics | No Action Indicated (NAI) | 3012792221 |
| May 18, 2017 | Rapid City, SD | Biologics | No Action Indicated (NAI) | 3006850594 |
| Aug 4, 2016 | Bismarck, ND | Biologics | No Action Indicated (NAI) | 3011394216 |
| Feb 28, 2014 | Rapid City, SD | Biologics | No Action Indicated (NAI) | 3006850594 |
| May 17, 2012 | Rapid City, SD | Biologics | No Action Indicated (NAI) | 3006850594 |
- 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 3012792221 | Fargo, ND | 3 | May 30, 2024 |
| FEI 3011394216 | Bismarck, ND | 4 | May 28, 2024 |
| FEI 3006850594 | Rapid City, SD | 4 | Apr 14, 2022 |
South Dakota Lions Eye And Tissue Bank Inc and the FDA: common questions
Has South Dakota Lions Eye And Tissue Bank Inc received an FDA warning letter?
No FDA warning letter addressed to the name "South Dakota Lions Eye And Tissue Bank Inc" 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 South Dakota Lions Eye And Tissue Bank Inc received an FDA Form 483?
FDA has not published a Form 483 for "South Dakota Lions Eye And Tissue Bank Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect South Dakota Lions Eye And Tissue Bank Inc?
The most recent FDA inspection on file ended May 30, 2024 at Fargo, ND and was classified NAI. FDA has 11 inspections of South Dakota Lions Eye And Tissue Bank Inc on file.
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