FDA Orders Johnson & Johnson Contractor to Pause Vaccine Production at Plant With Prior Contamination Issue
A contractor that makes ingredients for Johnson & Johnson’s COVID-19 vaccine said in an April 19 filing that federal regulators ordered a stoppage to its production of the drug substance for the duration of an inspection at a Maryland facility that was previously plagued with a contamination issue.
Emergent BioSolutions, which has a contract to manufacture bulk drug substance for Johnson & Johnson’s COVID-19 vaccine, stated in an SEC filing that the Food and Drug Administration (FDA) requested a pause in production of any new material at its Bayview facility in Baltimore, Maryland, while regulators carry out an inspection. The FDA also requested that existing vaccine substances be put into quarantine for the duration of the probe. Federal regulators launched the inspection on April 12.