On Apr. 21, 2021, the FDA announced that it had completed an inspection of the Emergent BioSolutions and cited a number of observations concerning whether the facilityﾒs processes met their requirements and standards.

Emergent BioSolutions paused production while it worked with the FDA to resolve potential quality issues. The FDA had not authorized the facility to manufacture or distribute any of Johnson & Johnsonﾒs COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant had been distributed for use in the U.S.