Jubilant HollisterStier Receives Zero Observations from Recent U.S. Food and Drug Administration Inspection

SPOKANE, WA. – Jubilant HollisterStier, a sterile fill-finish and injectable pharmaceutical contract manufacturing organization, announces that a United States Food and Drug Administration (USFDA) inspection, performed by the Center for Biologics Evaluation and Research (CBER), was completed successfully with zero form – 483 observations. The successful completion of this comprehensive inspection at the Spokane facility continues to enable customer access to JHS’s exceptional manufacturing capabilities for their clinical and commercial batches from an FDA approved site.

Inspectors reviewed all of the JHS manufacturing lines, including JHS’ new sterile-fill finish line (Line 3) that is a part of their current $285m facility expansion at their Spokane facility. The successful completion of this CBER inspection highlights the company’s dedication to ensuring the integrity of its operations and its focus on providing safe and effective products to its clients, and ultimately, patients worldwide.

“Receiving zero observations from CBER is a testament to the diligence and expertise of our team,” said Jerad Holcomb, Vice President of Quality at Jubilant HollisterStier. “We are committed to adhering to the most stringent quality standards, and this reflects in our collective dedication to operational excellence and patient safety.”

“This achievement not only demonstrates Jubilant HollisterStier’s leadership in quality and compliance, but also reinforces the trust that our clients and partners have in our capabilities,” said Ben VanGerpen, Chief Scientific Officer. “Our teams are dedicated to continuous improvement to meet the evolving regulatory requirements and maintain the highest standards of excellence.”

This zero observation inspection result strengthens Jubilant HollisterStier’s position as a premier CMO for biologics, providing clients with confidence in the company’s ability to consistently deliver high-quality products in compliance with regulatory guidelines.

About Jubilant HollisterStier:
Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharmova Limited, is an integrated contract manufacturer of sterile injectables, lyophilized products, sterile ointments, and ophthalmics. JHS is committed to providing exceptional manufacturing services to the pharmaceutical and biopharmaceutical industry in North America.

Media Contact:
Sarah Dolan
Jubilant HollisterStier, LLC.
Sarah.Dolan@jubl.com