FDA Inspection
Tiadent IncTiadent Inc – FDA Inspection, Feb 11, 2026
Record Details
This FDA Inspection record concerns Tiadent Inc, with an inspection on February 11, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · de044a3a-9c02-4166-b3b7-1e7065ef9319
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1302350
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- 21 CFR 803.17Lack of Written MDR Procedures
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