Rx-360 Partners with Leucine to Offer FDA Tracker Premium to Consortium Members

PHILADELPHIA, Nov. 25, 2025 /PRNewswire/ -- Rx-360, the International Pharmaceutical Supply Chain Consortium, is proud to announce a strategic partnership with Leucine, an AI-powered platform transforming pharmaceutical manufacturing and compliance through intelligent automation and data-driven insights. Through this collaboration, Rx-360 consortium members will now receive complimentary access to Leucine's FDA Tracker Premium, an advanced regulatory intelligence platform that helps pharmaceutical manufacturers proactively monitor FDA activity, assess risk, and stay continuously inspection-ready.

FDA Tracker Premium delivers real-time intelligence across FDA inspections, Form 483s, and warning letters—providing deep analytics on investigators, subsystems, and enforcement trends. The platform helps quality and compliance leaders predict potential risks, benchmark performance against industry peers, and prepare more effectively for upcoming inspections.

"This partnership reflects Rx-360's ongoing commitment as an international nonprofit, to improving supply chain integrity and patient safety," said Jim Fries, CEO of Rx-360. "By offering FDA Tracker Premium as part of Rx-360 membership, we're equipping the industry with the tools needed to maintain the highest standards of pharmaceutical quality."

"This collaboration with Rx-360 extends our mission to make compliance proactive, intelligent, and accessible," said Vivek Gera, CEO of Leucine. "FDA Tracker Premium empowers every manufacturer to anticipate regulatory risks, strengthen audit preparedness, and ultimately ensure patient safety."

The FDA Tracker Premium platform is powered by AI and leverages a comprehensive database of FDA inspection information and observations. It provides actionable intelligence across key subsystems such as Quality, Facilities, Laboratory Controls, Materials, Packaging, Production, and IT/Data Management through interactive dashboards and visual analytics.

Rx-360 consortium member company employees can visit https://rx-360.org/FDATracker/ to schedule a quick onboarding session and begin using the FDA Tracker Premium platform. This initiative is part of Rx-360's broader mission to foster collaboration, transparency, and innovation in the pharmaceutical supply chain.

For more information or to become a member, visit www.rx-360.org.

About Rx-360
Rx-360 is a global nonprofit pharmaceutical supply chain consortium established in 2009 with a mission to protect patient safety by advancing quality standards and fostering industry-wide collaboration. Through its Joint Audit Program®, Rx-360 delivers comprehensive, internationally recognized audit services and maintains an extensive library of completed audit reports to support efficient and informed supplier qualification. For more information, visit http://www.Rx-360.org or email [email protected]

About Leucine
Leucine is an AI-powered manufacturing and compliance platform that helps pharmaceutical companies stay compliant, audit-ready, and efficient. Built on a composable architecture, Leucine digitizes GMP workflows across Manufacturing, Quality, and Laboratories — enabling faster batch release, improved data integrity, and greater operational transparency.

Rx-360 Media Contact
Katie Battista, [email protected]

SOURCE Rx-360