Managing Medical Device Supplier and Purchasing Controls

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:

• What are the challenges associated with purchasing controls compliance?
• What are the most commonly identified inadequacies for Purchasing Controls?
• What is the intent of Purchasing Controls in 21 CFR Part 820?
• How should manufacturers approach Purchasing Controls compliance?
• How does compliance with 21 CFR Part 820.50 affect compliance with other quality standards?

We answer all of these questions and more in this white paper.

About the Author: Carrie Hetrick is a Senior Regulatory Consultant at Emergo.