Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our Health newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (April 21, 2021, 7:52 PM EDT ) The U.S. Food and Drug Administration said Wednesday that it found numerous shortcomings at an Emergent BioSolutions plant in Maryland that had been producing COVID-19 vaccines for Johnson & Johnson, including unclean facilities, inadequate waste handling and poorly trained personnel.
The FDA said in an announcement that it has wrapped up a probe into the Emergent BioSolutions facility that has been the source of a contamination of millions of Johnson & Johnson vaccine doses.
The report from the FDA said that the manufacturing building "is not maintained in a clean and sanitary condition," noting that paint on floors and walls was peeling.
Additionally, the FDA said that waste handling was subpar and that workers tasked with handling medical waste didn't follow procedures relating to how to handle nondisinfected waste.
And on top of other issues, the FDA said that manufacturing personnel were not properly trained, noting that some didn't follow the right gowning procedures.
But the "Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues," the FDA said, adding that vaccines already made at the site will go through more testing.
"We are doing everything we can to ensure 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 effectiveness," FDA said. "We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, they are putting their trust in us. We are working hard to maintain that trust."
Emergent BioSolutions said in a statement that it was "committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified."
"We deeply value the relationship we have with our manufacturing partners and with the FDA," Emergent BioSolutions said. "The FDA's feedback will help continue to improve and strengthen the supply chain for Johnson & Johnson's vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them."
The FDA's announcement came just two days after federal lawmakers said they were looking into contracts that Emergent BioSolutions had to produce the vaccines.
The lawmakers said that Johnson & Johnson vaccine doses were contaminated and had to be destroyed, although noted that none of those doses were meant for U.S. use.
Johnson & Johnson said in a statement that it will use its oversight role to make sure that all the problems identified by the FDA are solved.
"The company will also redouble its efforts as it continues to work toward securing emergency use authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible, so that the company can help bring an end to this global pandemic," Johnson & Johnson said.
The FDA said that the issues at the plant aren't related to the government's evaluation of six U.S. cases of rare and serious blood clots among those who received the Johnson & Johnson vaccine. Federal health officials last week recommended a pause of the administration of the Johnson & Johnson vaccine while it looked into the blood clot issue.
--Additional reporting by Britain Eakin. Editing by Amy Rowe.
For a reprint of this article, please contact reprints@law360.com.
