483
Proxtalker.Com, LlcProxtalker.Com, Llc – FDA 483, Nov 18, 2025
Record Details
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.
- Person
View Company Profile
ID · 0caef4f1-1ea0-4214-894d-96de96ed7364
Other documents for Proxtalker.Com, Llc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.