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FDA inspection report slams Emergent for quality and cleanliness breaches at Bayview facility

Gareth Carpenter — 22 Apr 2021

Company failed to investigate vaccine drug substance discrepancies thoroughly, says US regulator

A US Food and Drug Administration inspection of Emergent BioSolutions’ Bayview facility where Johnson & Johnson’s COVID-19 shot is manufactured found that the pharma contractor failed to investigate vaccine drug substance ingredient discrepancies thoroughly amid several cleanliness and quality control breaches.

Earlier this month, a batch of a key ingredient for the J&J single-shot vaccine at the Baltimore facility failed to meet quality control standards and up to 15 million doses were lost.

As a result, the US government asked J&J to take charge of production at Bayview, although manufacturing at the facility was halted earlier this week pending the results of the FDA inspection.

Published on Wednesday, the so-called ‘FDA Form 483’ report said Emergent failed to properly review personnel movements in and around the facility as a potential source of contamination, and did not consider that its raw material storage could be prone to contamination.

Once the ingredient mix-up was identified, no extra cleaning was performed beyond standard practices and the FDA came away with the verdict that “there is no assurance that other batches have not been subject to cross-contamination.”

“During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards,” the FDA said.

Among the FDA’s other observations were concerns about unsanitary conditions at the facility, such as waste not being correctly decontaminated and being transported through the warehouse before disposal.

Peeling paint on walls and wall damage at the factory were deemed to impact Emergent’s “ability to adequately clean and disinfect the area,” the FDA report said.

The FDA also said the size and design of the facility in relation to the volume of production it was undertaking was not suitable “to facilitate cleaning, maintenance, and proper operations.”

“We deeply value the relationship we have with our manufacturing partners and with the FDA,” Emergent said in a statement. “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.”

The FDA said that at the agency’s request, Emergent BioSolutions has agreed to pause new production while it works to resolve the potential quality issues.

“For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the FDA said.

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