The Baltimore plant contracted to make Johnson & Johnson’s COVID-19 vaccine dirty, did not follow proper manufacturing procedures, and had poorly trained personnel, resulting in contamination of the material to be fired, regulators said Wednesday. Americans.
The Food and Drug Administration has issued a 13-page statement and report detailing the findings of its recent inactive inspection. Emerging BioSciences Factory.
Agency inspectors said a batch of bulk drugs for the J&J monotone vaccine was contaminated with the material used to make COVID-19 vaccines for another emerging customer, AstraZeneca. That batch, enough to make about 15 million doses of J&J vaccine, had to be discarded.
Other issues cited in the inspection report were peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following contamination prevention procedures.
Nothing was distributed from the factory to J&J, the FDA said. The nearly 8 million doses of J&J vaccine given in the United States came from Europe.
Both Emergent and Johnson & Johnson said on Wednesday that they are working to fix the problems as soon as possible.
Production has stopped
After the quality problems appeared at the end of last month, J&J took control of the factory. The Biden administration is now working to move the manufacture of the AstraZeneca vaccine to another factory. The AstraZeneca vaccine is not yet licensed in the United States
The Baltimore plant shut down all production at the end of last week, at the request of the FDA. The Agency did not grant the factory the emergency approval that is required before the vaccine material manufactured there can be distributed.
All of the bulk substances that Emergent has produced, plus the early batches made there and then put into bottles and packaged by other J&J contractors, are stored and will be subjected to additional testing by the FDA, the agency said.
“We are doing everything we can to make sure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and efficacy,” the FDA said.
The use of the J&J vaccine is currently pending in the United States, as government health officials are investigating its possible link to very rare blood clots. Their decision to allow the vaccine could come on Friday. The factory inspection is not related to the ongoing assessment.
On Tuesday, the safety committee of the European Medicines Agency said its analysis had found blood clots are a very rare side effect, but the benefits of the J&J vaccine outweigh this risk.
Emergent, a contractor little known for making drugs, has been given a major role in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for issues ranging from poorly trained employees to cracked bottles and molds around one of its facilities, according to records obtained by The Associated Press.
Potential for contamination
FDA inspectors began inspecting the Emergent plant in Baltimore on April 12 and completed their investigation Tuesday.
Inspectors reviewed security camera footage showing employees carrying unsealed bags of medical waste to the factory, the bags touching materials ready to be used to make batches of vaccines. The images also showed employees moving between the production areas for the two vaccines without documenting whether they changed their protective clothing and went with each other as needed.
The inspection report stated that Emergent had not sufficiently investigated the contamination of the subsequently discarded J&J batch and did not appear to have made any further clean-up after the contamination was discovered.
“There is no assurance that other batches have not been subjected to cross-contamination,” the report said.
He also noted that the factory had inadequate procedures to ensure that the vaccinated substance met all quality and purity requirements.
It is unclear how long it will take companies to solve all the problems in 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.
“At this time, we cannot speculate on any potential impact it could have on the timing of our vaccine deliveries,” J&J said in a statement.