FDA 483 - Tiadent Inc - February 11, 2026

Tiadent Inc, a manufacturer and initial importer of medical devices in Rosenberg, TX, was cited for three significant issues during an FDA inspection. The firm failed to implement a risk-based approach for its Class II medical devices, lacked proper Medical Device Reporting (MDR) procedures, and did not comply with Unique Device Identification (UDI) requirements for its medical device labels and GUDID registration. These observations indicate deficiencies in the firm's quality management system and regulatory compliance.