FDA inspectors find “brown residue” and other violations at the plant that manufactures the Johnson & Johnson vaccine

The Baltimore plant contracted to manufacture 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 into the shots, U.S. regulators said Wednesday.

The Food and Drug Administration issued a 13-page statement and report outlining the results of its recent inspection of the now inactive Emergent BioSciences Factory.

Agency inspectors said a batch of drug substance in bulk for J & J’s single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. This batch, which was supposedly enough to make approx. 15 million J&J vaccine doses, had to be thrown out.

Other problems mentioned in the inspection report were peeling paint, black and brown residue on floors and walls of the factory, inadequate cleaning and staff not following procedures to prevent contamination.

Nothing manufactured at the J&J factory has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the United States came from Europe.

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

Production stopped

After quality issues surfaced late last month, J&J took control of the factory. The Biden administration is now working on moving AstraZeneca vaccine production to another factory. AstraZeneca’s vaccine is not yet approved in the United States

The Baltimore plant stopped all production late last week at the request of the FDA. The Agency has not given emergency approval to the factory, which is necessary before any vaccine material produced there can be distributed.

All bulk vaccine substance Emergent has made, plus early batches made there and then put in vials and packaged by other J&J contractors, is stored and will undergo further testing by the FDA, the agency said.

“We are doing everything we can to ensure that the COVID-19 vaccines given to the people of this nation have met the agency’s high standards of quality, safety and efficacy,” the FDA said.

Currently, the use of the J&J vaccine is on hold in the United States as government health officials investigate its possible link to very rare blood clots. Their decision on whether to give the vaccine could come on Friday. The factory inspection is not related to the ongoing evaluation.

On Tuesday, the European Medicines Agency’s safety committee said its review found blood clots is a very rare side effect, but the benefits of the J&J vaccine outweigh this risk.

Emergent, a lesser-known drug manufacturing entrepreneur, was given an important role in the Trump administration’s response to the coronavirus. The company has repeatedly been cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press.

Potential for contamination

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

Inspectors reviewed footage from security cameras showing employees carrying unsealed bags of medical waste at the factory, where the bags touched materials ready for use in the manufacture of vaccine batches. The recordings also showed that employees moved between the production areas for the two vaccines without documenting whether they changed protective dresses and bathed in between as needed.

The inspection report noted that Emergent did not adequately investigate the contamination of the later discarded J&J batch and did not appear to have performed any additional cleaning after the contamination was discovered.

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

It also noted that the factory had inadequate procedures to ensure that the vaccine substance met all quality and purity requirements.

It is unclear how long it will take companies to solve all the problems at the factory, known as Bayview.

J&J is committed to delivering 100 million doses to the United States by the end of May and 1 billion doses globally by the end of the year.

“Right now, we can not speculate on any potential impact this may have on the timing of our vaccine deliveries,” J&J said in a statement.