Emergent BioSolutions Receives NAI Status for Baltimore Bayview Manufacturing Facility
March 25 2024 - 8:05AM
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.
Safe Harbor StatementThis press release
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Investor Contact:Richard S. LindahlExecutive
Vice President, CFOlindahlr@ebsi.com
Media Contact:Assal HellmerVice President,
Communicationsmediarelations@ebsi.com
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