Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Warning Letter Roundup & Recap – January 5, 2016

This article was originally published in The Gray Sheet

Executive Summary

QS, MDR and correction & removal regulation violations noted at two separate Sorin Group manufacturing facilities; importer and distributor of whole body vibration devices sold the products without FDA premarket clearance and approval; and more. Three device warning letters were listed by FDA this week.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register