FDA 483 - Saphena Medical, Inc. - March 04, 2025

Saphena Medical, Inc. in West Bridgewater, MA, a manufacturer of the Venapax Endoscopic Vessel Harvesting Device, was cited for significant deficiencies during an FDA inspection. Observations included inadequate establishment of corrective and preventive action procedures, failure to submit a Medical Device Report (MDR) within the required timeframe, and insufficient procedures for receiving, reviewing, and evaluating complaints. These issues indicate systemic problems with the firm's quality system and compliance with medical device regulations.