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

Want A Quick Inspection? Have Records Prepped And Don't Dilly-Dally When Asked For Documents, FDA Investigators Advise

This article was originally published in The Gray Sheet

Executive Summary

When 86 percent of FDA domestic inspections are preannounced, it's difficult to imagine that manufacturers could be caught unprepared – yet many do not have the appropriate records ready for investigators when they knock on the front door. And an auditor's suspicion might be aroused when it takes a long time to retrieve a particular document, says investigator Laureen Geniusz, who recommends manufacturer transparency: "If the record is stored in a cave in Pennsylvania, let the investigator know that's why it’s going to take a while to get it."

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register