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FDA Cites Disinfection Issues at Proposed Vaccine Production Site

Agency finds issues to resolve at Baltimore-based facility.

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By: Christine Esposito

Editor-in-Chief

Following an inspection of Emergent BioSolutions, a Baltimore, MD-based manufacturing facility tapped to produce the Johnson & Johnson COVID-19 vaccine, FDA says it found a number of observations concerning whether the facility’s processes meet the agency’s requirements and standards. Among the issues noted were improper disinfection.      The observations were outlined in FDA’s inspection closeout report, also known as a FDA Form 483.  The FDA said the observations are intended to ide...

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