Medtronic Vascular, Inc. – FDA 483, Oct 15, 2021

Medtronic Vascular, Inc. in Danvers, MA, received a Form FDA 483 with three observations following an inspection. The firm was cited for failing to adequately validate processes, specifically regarding unvalidated release test methods used by a contract manufacturer for pediatric septostomy balloon catheters. Additionally, the inspection revealed inadequate documentation of corrective and preventive actions and a failure to establish proper procedures for ensuring purchased products conform to specified requirements, leading to the acceptance and distribution of non-conforming devices.