Apr 21, 2021 - Health

FDA: Plant that ruined millions of J&J doses had multiple failures

The Emergent BioSolutions plant in Baltimore in April 2021.
The Emergent BioSolutions plant in Baltimore in April 2021. Photo: Saul Loeb/AFP via Getty Images

The Baltimore Emergent BioSolutions manufacturing plant that ruined 15 million doses of Johnson & Johnson's coronavirus vaccine had multiple procedural failures, including unsanitary conditions near sensitive manufacturing areas, the Food and Drug Administration stated in a report Wednesday

Why it matters: The FDA faulted Emergent for failing to thoroughly review the incident, which halted the potential production and shipment tens of millions of Johnson & Johnson doses this month.

Context: Workers at the plant, which had been producing vaccine materials for Johnson & Johnson and AstraZeneca, conflated ingredients between the two different types of vaccines, destroying 15 million doses of the Johnson & Johnson vaccine.

The FDA said the plant suffered from multiple unsanitary conditions, including peeling paint in sensitive manufacturing areas and waste that was not decontaminated.

  • The administration said workers at the plant were also seen on surveillance footage mishandling medical waste.

What they're saying: Emergent told the Washington Post that it was working to correct problems identified in the inspection report.

  • "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.
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