J&J suffers new setback as FDA tells Md. vaccine maker to suspend production

Emergent’s brief statement Monday said the FDA began a new inspection of its Bayview facility on April 12. On Friday, at the FDA’s request, “Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings,’’ the company said. It said it was striving to make unspecified improvements “to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.”... Contamination with ingredients from a coronavirus vaccine made by AstraZeneca ruined 15 million doses of Johnson & Johnson’s vaccine last month. In response to that error, the Biden administration removed AstraZeneca manufacturing from the plant and put Johnson & Johnson in direct control of vaccine production there. AstraZeneca and Johnson & Johnson have not disclosed how many doses of vaccine have previously been shipped from the Emergent plant and put into vials by other manufacturers.