The Food and Drug Administration Wednesday released a scathing inspection report that cites multiple failures at the Emergent BioSolutions manufacturing plant in Baltimore that ruined 15 million doses worth of raw Johnson & Johnson coronavirus vaccine.
The FDA said Emergent failed to conduct a thorough review of the incident, in which vaccine ingredients from an AstraZeneca coronavirus vaccine were mixed with the Johnson & Johnson product.
The report says Emergent has identified a batch of media used to manufacture Johnson & Johnson vaccine as the most likely cause of the cross-contamination. But the report cites a ``failure to conduct thorough investigations into unexplained discrepancies.’'
It also cites a number of unsanitary conditions at the plant. It said waste was not decontaminated and that inspectors found peeling paint in sensitive manufacturing areas.
In another finding, the report said a review of security camera footage showed employees failing to follow proper procedures in the handling of medical waste.
Emergent said 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.
It called its employees, who are cited multiple times in the FDA report for not following procedures to prevent cross-contamination of vaccines, ``a heroic workforce who have stepped up to work 24/7 to ensure vaccines will be produced with the highest quality and quickly available to fight this pandemic.’'