FDA inspectors find “brown residue” and other violations in the production of the Johnson & Johnson vaccine

The Baltimore plant contracted to make Johnson & Johnson’s COVID-19 vaccine was dirty, did not follow proper manufacturing procedures and had poorly trained personnel, resulting in contamination of material that would be put in the shots US regulators said Wednesday.

The Food and Drug Administration has released a statement and a 13-page report detailing the findings of its recent inspection of the now inactive Emerging BioSciences plant.

Agency inspectors said a batch of the bulk drug for J & J’s single vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent customer, AstraZeneca. That batch, reportedly enough to make about 15 million J&J vaccine doses, had to be discarded.

Other issues identified in the inspection report included peeling paint, black and brown residue on floors and walls in the factory, inadequate cleaning, and failure to follow procedures to prevent contamination.

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 US came from Europe.

Both Emergent and Johnson & Johnson said on Wednesday that they are working to resolve the issues as quickly as possible.

Production has stopped

After quality problems surfaced late last month, J&J took over the factory. The Biden government is now working to move production of AstraZeneca vaccines to another plant. AstraZeneca’s vaccine has not yet been approved in the US.

The Baltimore plant ceased all production late last week at the request of the FDA. The agency has not given the factory emergency approval, which is necessary before the vaccine material made there can be distributed.

All of the bulk vaccine substances that Emergent has made, plus early batches made there and then bottled and packaged by other J&J contractors, will be stored and will undergo additional testing by the FDA, the agency said.

“We are committed to ensuring that the COVID-19 vaccines given to the people of this country meet the agency’s high standards for quality, safety and effectiveness,” said the FDA.

Currently, use of the J&J vaccine has been suspended in the US as government health officials are investigating the possible link to very rare blood clots. Their decision whether or not to give the vaccine could come Friday. The factory inspection is separate from the ongoing evaluation.

On Tuesday, the European Medicines Agency’s Safety Committee said its review has the blood clots are a very rare side effect, but the benefits of the J&J vaccine outweigh that risk.

Emergent, a little-known drug manufacturing contractor, was instrumental in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for issues ranging from poorly trained workers to cracked bottles and mold around one of its facilities, according to data obtained by The Associated Press.

Potential for contamination

FDA inspectors began checking the Emergent Baltimore plant on April 12 and concluded their investigation Tuesday.

The inspectors looked at security camera footage that showed workers carrying unsealed bags of medical waste at the plant, with the bags touching materials ready to be used to make vaccine batches. The images also showed workers moving between the production areas for the two vaccines without documenting whether they changed protective coats and showered in between, as required.

The inspection report noted that Emergent had not sufficiently investigated the contamination from the later discarded J&J batch and did not appear to have performed additional cleaning after the contamination was discovered.

“There is no guarantee that other batches have not been subject to cross-contamination,” the report said.

It also noted that the plant did not have sufficient procedures to ensure that the vaccine substance met all quality and purity requirements.

It is unclear how long it will take the companies to resolve all issues at the factory known as Bayview.

J&J has pledged to provide 100 million doses to the US by the end of May and 1 billion doses worldwide by the end of the year.

“At this point in time, we cannot speculate about the potential impact this could have on the timing of our vaccine deliveries,” J&J said in a statement.