FDA 483 - Proxtalker.Com, Llc - November 18, 2025

An FDA inspection of Proxtalker.Com, Llc in Waterbury, CT, a manufacturer of Class II medical devices, revealed significant deficiencies in their quality system. The firm failed to establish written procedures for Medical Device Reporting (MDR) and Corrective and Preventive Actions (CAPA). Additionally, the company did not register Unique Device Identifiers (UDIs) for its devices in the GUDID database, nor did it include them on device labels.