What are the most common inspectional observations that warrant an FDA Warning Letter citation (Form 483)? Believe it or not, Purchasing Controls is among the top three. Whether you have an audit coming or you’re implementing the Quality System Regulation (QSR), pay special attention to Purchasing Controls.
This white paper addresses one of the biggest vulnerabilities for medical device companies selling in the US. Take a deep dive into compliance with 21 CFR Part 820.50 - Purchasing Controls.
What you will learn in this 7-page white paper:
We answer all of these questions and more in this white paper.
About the Author: Carrie Hetrick is a Senior Regulatory Consultant at Emergo.