FDA 483 - Aerin Medical, Inc. - September 22, 2025

Aerin Medical, Inc. in Mountain View, CA, a specification developer, was cited for two observations during an FDA inspection. The firm's corrective and preventive action (CAPA) system was found inadequate in preventing the recurrence of late Medical Device Reports (MDRs). Additionally, the inspection revealed deficiencies in personnel training documentation, with one marketing employee's training file missing.