FDA probe found problems at factory making J&J vaccine

Facility was dirty, didn’t follow proper procedures, had poorly trained staff

The Baltimore factory hired to help 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 going into a batch of shots, U.S. regulators said Wednesday.

The Food and Drug Administration released a statement and a 13-page report detailing findings from its just-completed inspection of the idled Emergent BioSciences factory.

Agency inspectors said a batch of 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. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.

Other problems cited in the inspection report included peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine batches and ingredients.

Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.

Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.

After quality problems surfaced late last month, J&J took control of the factory. The Biden administration now is working to move AstraZeneca vaccine manufacturing to another factory. AstraZeneca has yet to seek emergency authorization for use of its vaccine in the U.S.

The Baltimore factory halted all production late last week at the FDA’s request. The agency hasn’t given emergency approval to the factory, which is needed before any vaccine material made there can be distributed.