Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration has listed “No Action Indicated” or NAI status classification for the company’s Baltimore Bayview manufacturing facility.
GAITHERSBURG, Md., March 25, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has listed “No Action Indicated” or NAI status classification for the company’s Baltimore Bayview manufacturing facility. Based on this outcome, the Baltimore Bayview facility is considered to be in an acceptable state of compliance with regard to current good manufacturing practices (cGMP).
“Quality and compliance excellence remains a top priority for Emergent and is embedded into our company culture and identity in service of our mission to protect and enhance life,” said Coleen Glessner, executive vice president, risk, regulatory, ethics and compliance and chief quality officer. “We are proud of our colleagues who have worked relentlessly to achieve this NAI status in Bayview.”
Emergent is committed to ensuring continued compliance with cGMP requirements and remains steadfast in manufacturing and delivering high-quality products for the customers, partners, and patients it serves.
“This news is a result of the commitment and actions our cross-functional teams have taken to strengthen our operational quality and compliance systems across our manufacturing network,” said Bill Hartzel, senior vice president, manufacturing and bioservices. “We will continue to put quality and compliance first in our manufacturing operations to ensure we’re delivering high quality products to our customers and patients.”
The result of obtaining NAI status in Bayview is a continuation of Emergent’s strong commitment to quality and compliance. In 2023, Emergent manufacturing facilities were successfully inspected by five regulatory agencies across the globe and five other inspectional bodies for 18 inspections, including three by the FDA that resulted in NAI or VAI status. This includes the closing of the Baltimore - Camden Warning Letter in 14 months.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
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Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com
Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com
