Posted by Michael Wonder on 21 Apr 2021
FDA continues important steps to ensure quality, safety and effectiveness of authorised COVID-19 vaccines
21 April 2021 - The U.S. FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously.
The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness.
As part of our regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine. As Johnson & Johnson announced last month, the FDA has not authorised this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S.
