Risk Management To Drive Toughened CDRH Compliance Approach
This article was originally published in The Silver Sheet
Executive Summary
FDA DEVICE ENFORCEMENT ACTIVITIES will focus on companies that fail to ensure strict QS regulatory compliance at subsidiaries, with Office of Compliance Director Timothy Ulatowski warning of upcoming corporate-wide legal actions. Companies marked by a series of poor inspections are particularly likely to be targeted amidst an enforcement climate that top FDA officials and outside observers alike describe as increasingly aggressive. To gain information about the most serious violations at device firms, OC is transitioning to a risk-based inspection agenda and new systems for analyzing recalls, MDRs and MedSun reports. Also on the enforcement chief’s front burner: a crackdown on misleading promotions and ads