Amylior, Inc. FDA Record
- Latest inspection VAI · Nov 9, 2017
- No warning letters matched by name
Amylior, Inc. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amylior, Inc." is on file.
- Latest inspection
- Nov 9, 2017 · VAI
- Latest 510(k)
- Oct 9, 2009
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 | 3 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | 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 |
|---|---|---|---|---|
| Nov 9, 2017 | Vaudreuil-Dorion, Canada | Devices | Voluntary Action Indicated (VAI) | 3003767999 |
- 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 3003767999 | Vaudreuil-Dorion, Canada | 1 | Nov 9, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K092225 | AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR | Oct 9, 2009 |
| K994107 | AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS. | Jan 13, 2000 |
| K994072 | AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM | Jan 13, 2000 |
Amylior, Inc. and the FDA: common questions
Has Amylior, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Amylior, Inc." 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 Amylior, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Amylior, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amylior, Inc.?
The most recent FDA inspection on file ended Nov 9, 2017 at Vaudreuil-Dorion, Canada and was classified VAI. FDA has 1 inspection of Amylior, Inc. on file.
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