Statement on Issuance of Form FDA 483 at Emergent Bayview Facility
April 21 2021 - 12:46PM
The U.S. Food and Drug Administration (FDA) has completed its
inspection of Emergent BioSolutions’ (NYSE:EBS) Baltimore-Bayview
facility and provided specific feedback. Given the heightened focus
on this facility, the FDA has proactively shared its findings to
keep the public, policymakers and all other stakeholders informed.
The issuance of findings by the FDA is normal following a facility
inspection and provides direction on the necessary steps to improve
operations. Emergent is committed to working with the FDA and
Johnson & Johnson to quickly resolve the issues identified.
We deeply value the relationship we have with our manufacturing
partners and with the FDA. The FDA’s feedback will help us continue
to improve and strengthen the supply chain for Johnson &
Johnson’s COVID-19 vaccine. While we are never satisfied to see
shortcomings in our manufacturing facilities or process, they are
correctable and we will take swift action to remedy them.
We are exceedingly proud of our heroic workforce in Baltimore
who have stepped up to work 24/7 to ensure vaccines will be
produced with the highest quality and be quickly available to fight
this pandemic.
About Emergent BioSolutionsEmergent
BioSolutions is a global life sciences company whose mission is to
protect and enhance life. Through Emergent’s specialty products and
contract development and manufacturing services, Emergent is
dedicated to providing solutions that address public health
threats. Through social responsibility, Emergent aims to build
healthier and safer communities. Emergent aspires to deliver peace
of mind to its patients and customers so they can focus on what’s
most important in their lives. In working together, Emergent
envisions protecting or enhancing 1 billion lives by 2030. For
additional information, visit Emergent’s website and
follow Emergent
on LinkedIn, Twitter and Instagram.
Safe Harbor StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact, including statements
regarding our supply chain and resolution of the issues identified
and any other statements containing the words “believes,”
“expects,” “anticipates,” “intends,” “plans,” “estimates” and
similar expressions, are forward-looking statements. These
forward-looking statements are based on our current intentions,
beliefs and expectations regarding future events. We cannot
guarantee that any forward-looking statement will be accurate. The
reader should realize that if underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual
results could differ materially from our expectations. Readers are,
therefore, cautioned not to place undue reliance on any
forward-looking statement. Any forward-looking statement speaks
only as of the date of this press release, and, except as required
by law, we do not undertake to update any forward-looking statement
to reflect new information, events or circumstances.
There are a number of important factors that could cause the
company's actual results to differ materially from those indicated
by such forward-looking statements. The reader should consider this
cautionary statement, as well as the risk factors identified in our
periodic reports filed with the SEC, when evaluating our
forward-looking statements.
Media Contact:Matt HartwigDirector, Media
RelationsHartwigM@ebsi.comInvestor Contact:Robert
G. BurrowsVice President, Investor
RelationsBurrowsR@ebsi.com
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