Prisma Health Office Of Human Research And Protection IRB FDA Record
- Latest inspection NAI · Mar 29, 2024
- No warning letters matched by name
Prisma Health Office Of Human Research And Protection IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Prisma Health Office Of Human Research And Protection IRB" is on file.
- Latest inspection
- Mar 29, 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 | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 29, 2024 | Greenville, SC | Devices | No Action Indicated (NAI) | 1036809 |
| Jun 15, 2016 | Greenville, SC | Drugs | No Action Indicated (NAI) | 1036809 |
| Feb 11, 2010 | Greenville, SC | Devices | No Action Indicated (NAI) | 1036809 |
- 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 1036809 | Greenville, SC | 3 | Mar 29, 2024 |
Prisma Health Office Of Human Research And Protection IRB and the FDA: common questions
Has Prisma Health Office Of Human Research And Protection IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Prisma Health Office Of Human Research And Protection IRB" 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 Prisma Health Office Of Human Research And Protection IRB received an FDA Form 483?
FDA has not published a Form 483 for "Prisma Health Office Of Human Research And Protection IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Prisma Health Office Of Human Research And Protection IRB?
The most recent FDA inspection on file ended Mar 29, 2024 at Greenville, SC and was classified NAI. FDA has 3 inspections of Prisma Health Office Of Human Research And Protection IRB on file.
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