FDA Inspection
Toothsmiths IncorporatedToothsmiths Incorporated – FDA Inspection, May 21, 2026
Record Details
This FDA Inspection record concerns Toothsmiths Incorporated, with an inspection on May 21, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9969674f-88bb-4019-963a-e008f93d7e46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1318234
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 5.6.2Input to management review is incomplete
- ISO 13485:2016 Clause 7.5.6Procedures for production/service provision software validation not documented
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