FDA inspection insights


MasterControl Inc., provider of innovative quality management software solutions, recently released an article addressing facility inspections. Many medical device firms receive Form 483 citations from the FDA because of issues related to quality audits, corrective and preventive actions, employee training records, and documentation control. In its Q&A article, MasterControl interviews a medical device specialist with the FDA’s Office of Regulatory Affairs (ORA) who has spent the past twelve years inspecting domestic and international medical device companies. The article discusses several important topics, including the twelve most common problems pertaining to quality audit; things that FDA investigators look for in terms of CAPA and training control; and what medical device firms should do to prepare for an FDA inspection. To download a copy, visit www.mastercontrol.