F.D.A. Inspectors Discover Shortcomings at Emergent Vaccine Plant in Baltimore

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F.D.A. Inspectors Find Shortcomings at Emergent Vaccine Plant in Baltimore

Federal regulators on Wednesday released extremely critical results from their inspection of a Baltimore plant that was forced to dispose of up to 15 million doses of Johnson & Johnson's coronavirus vaccine and ordered all production to be temporarily suspended.

The Food and Drug Administration cited a number of shortcomings in the huge facility operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent workers had contaminated a batch of Johnson & Johnson cans with the virus that AstraZeneca made the vaccine from.

Violations included inadequate disinfection of the factory and its equipment, as well as failure to follow procedures to prevent contamination of the cans and to ensure the proper strength and purity of the vaccine produced there. In a 12-page report, the inspectors listed a total of nine violations, ranging from the design of the building to improperly trained staff. The inspection ended on Tuesday.

In a statement, the F.D.A. It was advised that Emergent is not authorized to distribute doses of Johnson & Johnson vaccines and that no vaccine manufactured at its facility has been approved for use in the United States.

AstraZeneca's vaccine is not yet approved for use in the United States, and all of the Johnson & Johnson doses administered in the country to date have been manufactured overseas. At the agency's request, the entire production facility was stopped.

"We will only allow the release of products when we are sure that they meet our quality expectations," says Dr. Janet Woodcock, Acting Commissioner of the FDA, and Dr. Peter Marks, the agency's lead vaccine regulator. said.

The agency said it was working with Emergent to fix the issues.

Inspectors criticized Emergent's response to last month's discovery that the Johnson & Johnson cans were contaminated with the AstraZeneca virus. The incident "has not been fully investigated," they wrote.

For example, Emergent did not monitor the movement of workers between the zones where each vaccine was made. "There is no guarantee that other batches have not been contaminated," they said.

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