Roper St. Francis Healthcare — FDA Facility Profile
Roper St. Francis Healthcare is an FDA-inspected facility (FEI 1000305447) located in Charleston, SC, US. RegDataLab tracks 7 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 7, 2025: No Action Indicated (NAI)
- Inspections on record
- 7 (1 VAI, 6 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 7, 2025 | No Action Indicated (NAI) | No citations listed |
| Mar 9, 2022 | No Action Indicated (NAI) | No citations listed |
| Dec 13, 2018 | No Action Indicated (NAI) | No citations listed |
| May 25, 2017 | No Action Indicated (NAI) | No citations listed |
| Jun 23, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 28, 2013 | No Action Indicated (NAI) | No citations listed |
| Aug 5, 2011 | Voluntary Action Indicated (VAI) | Legibility and indelibility (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
Facility details
- Company
- Roper St. Francis Healthcare
- Location
- Charleston, SC (US)
- Source
- inspections