Kevin Stein, M.D. FDA Record
Kevin Stein, M.D. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kevin Stein, M.D." is on file.
- Latest inspection
- Apr 23, 2025 · VAI
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 | 1 | Nov 14, 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 |
|---|---|---|---|---|
| Apr 23, 2025 | Winston Salem, NC | Drugs | Voluntary Action Indicated (VAI) | 3035158209 |
- 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 3035158209 | Winston Salem, NC | 1 | Apr 23, 2025 |
Kevin Stein, M.D. and the FDA: common questions
Has Kevin Stein, M.D. received an FDA warning letter?
No FDA warning letter addressed to the name "Kevin Stein, M.D." 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 Kevin Stein, M.D. received an FDA Form 483?
FDA has not published a Form 483 for "Kevin Stein, M.D." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kevin Stein, M.D.?
The most recent FDA inspection on file ended Apr 23, 2025 at Winston Salem, NC and was classified VAI. FDA has 1 inspection of Kevin Stein, M.D. on file.
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