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Ep 24 – Manufacturer Audits: Staying Organized and In Scope

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 >

Virtue 340B

Virtue 340B News & Announcements

Virtue 340B® provides independent 340B risk oversight for hospitals and health systems operating in an increasingly complex and scrutinized program environment. Rather than managing programs or selling technology, Virtue delivers objective, independent analysis that helps leadership understand where hidden exposure may exist, what that exposure could mean operationally or financially, and whether current oversight would stand up under external scrutiny. Our work translates complex 340B operational realities into clear, defensible insights that executives can act on with confidence.
Through independent audits, mock HRSA audit simulations, and continuous compliance monitoring, Virtue 340B® helps organizations detect operational drift early, strengthen oversight structures, and maintain durable, audit-ready programs. By focusing on prevention, visibility, and governance, not just technical compliance, Virtue 340B equips leadership teams with the clarity they need to protect their organizations and confidently defend how their 340B programs are being managed.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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