Roper St. Francis Healthcare FDA Record
- Latest inspection NAI · May 7, 2025
- No warning letters matched by name
Roper St. Francis Healthcare has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Roper St. Francis Healthcare" is on file.
- Latest inspection
- May 7, 2025 · 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
Roper St. Francis Healthcare: 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 7, 2025 | Charleston, SC | Biologics | No Action Indicated (NAI) | 1000305447 |
| Mar 9, 2022 | Charleston, SC | Biologics | No Action Indicated (NAI) | 1000305447 |
| Dec 13, 2018 | Charleston, SC | Biologics | No Action Indicated (NAI) | 1000305447 |
| May 25, 2017 | Charleston, SC | Biologics | No Action Indicated (NAI) | 1000305447 |
| Jun 23, 2015 | Charleston, SC | Biologics | No Action Indicated (NAI) | 1000305447 |
| Jun 28, 2013 | Charleston, SC | Biologics | No Action Indicated (NAI) | 1000305447 |
| Aug 5, 2011 | Charleston, SC | Biologics | Voluntary Action Indicated (VAI) | 1000305447 |
- 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 1000305447 | Charleston, SC | 7 | May 7, 2025 |
Roper St. Francis Healthcare and the FDA: common questions
Has Roper St. Francis Healthcare received an FDA warning letter?
No FDA warning letter addressed to the name "Roper St. Francis Healthcare" 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 Roper St. Francis Healthcare received an FDA Form 483?
FDA has not published a Form 483 for "Roper St. Francis Healthcare" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Roper St. Francis Healthcare?
The most recent FDA inspection on file ended May 7, 2025 at Charleston, SC and was classified NAI. FDA has 7 inspections of Roper St. Francis Healthcare on file.
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