EBS - FDA Cites Drawbacks at Emergent BioSolutions Vaccine Plant
On Wednesday, The Food and Drug Administration revealed that Emergent BioSolutions (NYSE: EBS) Baltimore plant, which manufactured Johnson and Johnson Covid-19 vaccines, was unsanitary and unsuitable to produce the shots. The FDA had previously halted the production of the plant as it performed its investigation.
“The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances,” the FDA investigators wrote in the report.
The FDA emphasized that it has not approved Emergent for distribution of J&J’s vaccines, therefore no vaccine produced at the plant has been dispensed within the United States.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the statement from Dr. Janet Woodcock, the F.D.A.’s acting commissioner, and Dr. Peter Marks, the agency’s top vaccine regulator, said.
The report conducted by the FDA details Emergent’s plant as “overcrowded” as well as “congested” with a variety of material close to one another and a struggle to walk the floor without colliding with equipment. Furthermore, examiners highlighted peeling paint within the facility and inappropriate decontamination of waste.
Nevertheless, the agency said it is actively working with Emergent to rectify the issues at hand.
Emergent said that it is working with FDA and J&J to resolve the problem quickly. “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,” the company said in a statement.
It added that “the issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations.”
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FDA Cites Drawbacks at Emergent BioSolutions Vaccine Plant