Spa Dent Inc. FDA Record
- Latest inspection NAI · May 26, 2023
- No warning letters matched by name
Spa Dent Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Spa Dent Inc." is on file.
- Latest inspection
- May 26, 2023 · NAI
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 | 0 | 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 |
|---|---|---|---|---|
| May 26, 2023 | Cambridge, Canada | Drugs | No Action Indicated (NAI) | 3011800195 |
- 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 3011800195 | Cambridge, Canada | 1 | May 26, 2023 |
Spa Dent Inc. and the FDA: common questions
Has Spa Dent Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Spa Dent 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 Spa Dent Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Spa Dent Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Spa Dent Inc.?
The most recent FDA inspection on file ended May 26, 2023 at Cambridge, Canada and was classified NAI. FDA has 1 inspection of Spa Dent Inc. on file.
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