19.3 C
New York
Tuesday, June 15, 2021

FDA inspectors found “brown residue” and other violations at Johnson & Johnson vaccine-making plant

US regulators said the Baltimore factory was contracted to manufacture Johnson & Johnson’s COVID-19 vaccine, which did not follow proper manufacturing procedures and had poorly trained workers, resulting in contaminating the material.

Food and Drug Administration released Statement And a 13-page report detailing findings from the recent inspection of the now defunct Emergent Biosciences Factory.

Agency inspectors said a batch of bulk drug substances for J & J’s single-shot vaccine were contaminated with the material used to make the COVID-19 vaccine for another emergency client, AstraZeneca. The batch reportedly had to be thrown out to make about 15 million J&J vaccine supplements.

Other problems cited in the inspection report were peeling paint, black and brown residues on the floor and walls in the factory, inadequate cleaning and staff not following procedures to prevent contamination.

Nothing has been delivered to the factory for J&J, the FDA noted. About 8 million doses of the J & J vaccine given in the US came from Europe.

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

Production stopped

After quality problems surfaced at the end of last month, Jammu and Kashmir took control of the factory. The Biden administration is now working to move the AstraZeneca vaccine manufacturing to another factory. AstraZeneca vaccine is not currently authorized in the US

The Baltimore factory halted all production last weekend at the request of the FDA. The agency has not given emergency approval to the factory, which is required before any vaccine material can be delivered.

The agency said that all bulk vaccine materials are made by Emergent, as well as initial batches made there and then packed by vials and other J&J contractors, are being stored and will have to undergo additional testing.

The FDA stated, “We are doing everything to ensure that the COVID-19 vaccines that are given to the people of this country meet the agency’s high standards for quality, safety and effectiveness.”

Currently, the use of the J&J vaccine continues in the US as government health officials investigate possible connections to very rare blood clots. His decision on whether to allow vaccines may come on Friday. Factory inspection is unrelated to ongoing evaluation.

The European Medicines Agency’s Safety Committee on Tuesday said its review found Blood clots There are a very rare side effect but it puts the benefits of Jammu and J vaccines at risk.

A well-known drug manufacturing contractor, Emergent was given a prominent role in the Trump administration’s response to coronovirus. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to broken vials and molds, according to records obtained by The Associated Press.

Potential for contamination

FDA inspectors began an investigation into the Amergent factory in Baltimore on April 12 and concluded its investigation on Tuesday.

Inspectors reviewed footage from the security camera that showed employees were carrying unsalted bags of medical waste to the factory, with the bags ready to touch the vaccine with the material. The footage showed employees moving between manufacturing areas for two vaccines without asking if they changed protective gowns and showered as needed.

The inspection report noted that Emergent did not adequately investigate the contamination of abandoned J&J batches later and did not make any additional cleanup after the contamination was discovered.

The report states that there is no assurance that other batches are not subject to cross-contamination.

It was also stated that the factory had inadequate procedures to ensure that the vaccine material met all the quality and purity requirements.

It is not clear how long it will take for companies to solve all the problems in the factory, this is called buyview.

J&J has promised 100 million doses for the US by the end of May and 1 billion doses globally by the end of the year.

“Right now, we cannot speculate on any possible effects that our vaccine may have on delivery times,” J&J said in a statement.

Latest news

Related news

LEAVE A REPLY

Please enter your comment!
Please enter your name here