The Baltimore factory contracted to make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material that was going to be put in the shots, U.S.
regulators said Wednesday. The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent Biosciences factory.
Agency inspectors said a batch of the bulk drug substance for J&J's single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca.