Innovize LLC FDA Record
Innovize LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Innovize LLC" is on file.
- Latest inspection
- Mar 26, 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 | 2 | 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 |
|---|---|---|---|---|
| Mar 26, 2025 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3007867940 |
| Jan 21, 2016 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3007867940 |
- 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 3007867940 | Saint Paul, MN | 2 | Mar 26, 2025 |
Innovize LLC and the FDA: common questions
Has Innovize LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Innovize LLC" 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 Innovize LLC received an FDA Form 483?
FDA has not published a Form 483 for "Innovize LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Innovize LLC?
The most recent FDA inspection on file ended Mar 26, 2025 at Saint Paul, MN and was classified NAI. FDA has 2 inspections of Innovize LLC on file.
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