Company
United StatesRoper St. Francis Healthcare, Charleston, SC – FDA Inspections
Inspection records and compliance data for Roper St. Francis Healthcare in Charleston, South Carolina. 7 FDA inspections on record, last inspected May 07, 2025.
Company Profile
This profile covers Roper St. Francis Healthcare based in Charleston, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2011. Last inspected May 7, 2025.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Legibility and indelibility1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 7, 2025 | Not classified | Biologics | 1272023 |
| March 9, 2022 | NAI | Biologics · Blood and Blood Products | 1164602 |
| December 13, 2018 | NAI | Biologics · Blood and Blood Products | 1076681 |
| May 25, 2017 | NAI | Biologics · Blood and Blood Products | 1014038 |
| June 23, 2015 | NAI | Biologics · Blood and Blood Products | 931444 |
| June 28, 2013 | NAI | Biologics · Blood and Blood Products | 838399 |
| August 5, 2011 | VAI | Biologics · Blood and Blood Products | 741069 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Roper St. Francis Healthcare
FEI Number
1000305447
Address
316 Calhoun St, Charleston, South Carolina 29401, United States
Country
United States
ID: 90fff450-777d-444a-b74b-71ed6e499e21