FDA launches investigation into last month’s dose contamination
According to a published report by Reuters, the production of Johnson & Johnson's Covid-19 vaccine at a US manufacturing plant was stopped by the FDA, as the agency looks into an error that caused in millions of doses to be contaminated last month.
Emergent BioSolutions Inc, the organization that owns and runs the Baltimore plant that had been making vaccine for J&J, stated in a regulatory filing that on April 16, FDA requested a pause in production of new drug substance for the shot pending completion of the inspection.
J&J said it would cooperate with Emergent and FDA to address any issues following the inspection, Reuters reports.
Strategic Trends in Pharmaceutical Manufacturing for Industry Leaders
March 10th 2025This link in the pharma supply chain is undergoing a major transformation propelled by technological advancements, regulatory changes, and evolving market dynamics, requiring industry leaders to adopt innovative strategies in order to remain competitive.