FDA inspection of Emergent's COVID-19 vaccine plant identifies 'potential quality issues'

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Shares of Emergent BioSolutions Inc. EBS, -0.03% were up 1.3% in trading on Wednesday after the Food and Drug Administration said it inspected a plant in Baltimore that had been scheduled to begin producing Johnson & Johnson's JNJ, -0.16% COVID-19 vaccine after reports emerged of cross-contamination in vaccine production there. J&J confirmed several weeks ago that quality standards had not been met at the Emergent facility. The FDA said that none of the vaccines produced at the facility in question have been distributed, and Emergent is working to address the regulator's concerns. "At the agency's request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues," the FDA said in a statement. The agency's so-called form 483 identified a number of problems at the plant, including a lack of "thorough review" of how workers move throughout the facility and poor decontamination practices. Emergent is the U.S. manufacturing partner for the J&J shot in the U.S. Emergent's stock is down 25.8% for the year, while the broader S&P 500 SPX, +0.64% has gained 10.1%.

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