FDA 483 - SensiMedical LLC - January 19, 2024

SensiMedical LLC, an initial importer in Miami, FL, was inspected regarding its Class II sterile medical devices. The inspection revealed a significant deficiency where the firm failed to establish a design history file and adequate design control procedures for its intravascular administration sets, despite continuing to distribute these devices. This indicates a serious lack of compliance with medical device regulations.