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Emergent BioSolutions Facility Needs to Be Improved, FDA Says

The facility where Emergent is producing Johnson & Johnson's single-dose vaccine has to make some changes, according to regulators.
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Emergent BioSolutions  (EBS) - Get Emergent Biosolutions Inc. Report shares were up slightly Wednesday after the U.S. Food and Drug Administration said it completed its inspection of the company's plant in Baltimore, which makes the Johnson & Johnson  (JNJ) - Get Johnson & Johnson Report COVID vaccine. 

Regulators asked for remediation of issues, including peeling paint and loose debris at the site. Earlier this week, Emergent said that it would stop production of new drug material at the plant during the FDA inspection. 

The FDA's inspection report, also known as FDA Form 482, cited observations including the failure to train personnel to avoid cross contamination of COVID-19 vaccines from JNJ and AstraZeneca  (AZN) - Get AstraZeneca PLC Report

The FDA also said that the building used for manufacturing the components of the two vaccines was not of suitable size and design to facilitate cleaning and maintenance. 

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Last month, Johnson & Johnson took over operations at the facility after an error caused the site to discard about 15 million doses of the company's vaccine. 

The facility has not been authorized by the FDA to manufacture or distribute any of Johnson & Johnson's COVID-19 vaccine or components and, to date, no vaccine manufactured at the plant has been distributed for use in the U.S. 

Johnson & Johnson said Monday that it remains committed to delivering 100 million doses of its single-shot vaccine to the U.S. after the Food & Drug Administration asked Emergent BioSolutions to stop manufacturing ingredients at its Baltimore factory. 

Last week, the Centers for Disease Control and Prevention and the Food and Drug Administration suspended use of the drugmaker's coronavirus vaccine amid concerns about blood clotting cases after six people -- among nearly 7 million who received the single-dose shot -- were found to have developed issues within two weeks of receiving the shot.

Emergent shares were up 0.4% at last check. Johnson & Johnson shares were down 0.2%.