Al,
National Competent Authorities (a conglomerate of the "FDAs" of each memberstate of the EU) are in general accompanying the audits of Notified Bodies at the manufacturing sites.
Or have you been approached by ANSM directly to be inspected?
Kind Regards
René
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Rene Becker
Regulatory Affairs and Quality Management Consultant
LEMAN LIFESCIENCE
Switzerland
Original Message:
Sent: 18-May-2016 03:42
From: Siegfried Schmitt
Subject: ANSM in France?
I have indeed. What particular element of the inspection is of interest to you?
They do follow the EU agencies' agreed common practices for inspections by national competent authorities
Regards
Siegfried