Manufacturer audits require more than document production. They require organization, scope discipline, and clear communication.
In this episode of Katy’s 340B Compass, Katy Lees discusses how covered entities can approach manufacturer audits with a structured response process. The conversation covers what to consider when a Good Faith Inquiry moves toward an audit, when to seek legal or consultant guidance, and why written communication can help support clarity.
Katy also highlights a critical oversight point: stay within the approved audit scope. That means focusing on the specific drugs and timeframe under review, even when broader program details may feel connected.
For compliance leaders, pharmacy teams, and health system executives, this episode offers practical insight into responding professionally while demonstrating program knowledge and compliance safeguards.
Visit Virtue 340B’s website to watch the episode on YouTube or listen on Spotify and other podcast platforms. Watch now >


