Prisma Health Outsourcing Facility
FDA Regulatory Profile
Prisma Health Outsourcing Facility has 1 FDA recall, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0648-2021 · Class III · Jun 8, 2021
- Latest inspection
- Mar 3, 2023 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0648-2021 | Class III | Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health… | Jun 8, 2021 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Mar 3, 2023 | Simpsonville, SC | Drugs | Voluntary Action Indicated (VAI) | 3015162096 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3015162096 | Simpsonville, SC | 1 | Mar 3, 2023 |