Immunization Archives - Page 3 of 120 - MPR


FDA: Issues Identified at Proposed Manufacturing Facility for Janssen COVID-19 Vaccine

In an effort to ensure the safety and quality of authorized COVID-19 vaccines, the Food and Drug Administration (FDA) recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Janssen COVID-19 vaccine. Following the inspection, the FDA noted several potential quality and safety issues at the Baltimore-Bayview facility. These included: A failure…