Inspections conducted by France’s ANSM of makers of implantable defibrillation leads found qualification and validation processes were the largest compliance problems.
Between November 2013 and June 2014 the agency conducted audits at six sites for St. Jude Medical, Medtronic, Boston Scientific and Sorin. German manufacturer Biotronik refused to be inspected.
Findings revealed manufacturers generally met EC marking requirements.
The areas identified for improvement were:
In terms of risk analysis, major deviations encountered were:
The agency noted that an injunction was issued to one devicemaker for two of its sites in Minnesota and Puerto Rico for failure to demonstrate biocompatibility of products and gaps in validation processes.
Read the inspection report here: www.fdanews.com/05-26-16-ANSMInspectionReport.pdf. — Joya Patel