Michio Hirano, M.D. FDA Record
Michio Hirano, M.D. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Michio Hirano, M.D." is on file.
- Latest inspection
- Apr 3, 2025 · NAI
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 3, 2025 | New York, NY | Drugs | No Action Indicated (NAI) | 3035529243 |
- 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 3035529243 | New York, NY | 1 | Apr 3, 2025 |
Michio Hirano, M.D. and the FDA: common questions
Has Michio Hirano, M.D. received an FDA warning letter?
No FDA warning letter addressed to the name "Michio Hirano, 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 Michio Hirano, M.D. received an FDA Form 483?
FDA has not published a Form 483 for "Michio Hirano, M.D." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Michio Hirano, M.D.?
The most recent FDA inspection on file ended Apr 3, 2025 at New York, NY and was classified NAI. FDA has 1 inspection of Michio Hirano, M.D. on file.
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