FDA 483 - Proxtalker.Com, Llc - June 08, 2023

Proxtalker.com, Llc in Waterbury, CT was inspected by the FDA from June 6-8, 2023. The inspection revealed a significant issue regarding the lack of documented acceptance activities and quality testing results within the device history records for their powered communication system medical devices. This indicates a serious deficiency in their quality system for medical device manufacturing.