ImpactOrtho Inc Hawaii FDA Record
ImpactOrtho Inc Hawaii has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "ImpactOrtho Inc Hawaii" is on file.
- Latest inspection
- Feb 28, 2019 · 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 |
|---|---|---|---|---|
| Feb 28, 2019 | Honolulu, HI | Biologics | Voluntary Action Indicated (VAI) | 3014328922 |
- 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 3014328922 | Honolulu, HI | 1 | Feb 28, 2019 |
ImpactOrtho Inc Hawaii and the FDA: common questions
Has ImpactOrtho Inc Hawaii received an FDA warning letter?
No FDA warning letter addressed to the name "ImpactOrtho Inc Hawaii" 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 ImpactOrtho Inc Hawaii received an FDA Form 483?
FDA has not published a Form 483 for "ImpactOrtho Inc Hawaii" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect ImpactOrtho Inc Hawaii?
The most recent FDA inspection on file ended Feb 28, 2019 at Honolulu, HI and was classified VAI. FDA has 1 inspection of ImpactOrtho Inc Hawaii on file.
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