The Food and Drug Administration said Wednesday a Baltimore plant that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable to manufacture the shots.
The FDA asked Emergent BioSolutions, which runs the plant, to temporarily stop producing materials for Covid-19 vaccines earlier this month as the U.S. agency initiated an inspection.
“The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances,” the FDA investigators wrote in the report.
The inspection, which was conducted earlier this month over a period of 8 days, revealed a raft of alarming quality issues found throughout the facility.
In a 13-page report, inspectors wrote that the facility used to manufacture the vaccine was “not maintained in a clean and sanitary condition” and was “not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations.”
FDA inspectors said paint was observed to be peeling in multiple areas and walls were damaged that could impact the plant’s “ability to adequately clean and disinfect.” They also noted that employees did not follow standard operating procedures in handling waste or vaccine manufacturing materials to ensure they weren’t contaminated.
The facility has not been authorized by the FDA to manufacture or distribute Johnson & Johnson’s Covid-19 vaccine, and none of the doses manufactured at this plant has been distributed for use in the United States. Emergent has agreed to pause production of materials until the issues the FDA identified are resolved, the agency said.
In a statement, J&J said it has increased “its oversight of drug substance manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure the quality standards of our company and the U.S. Food & Drug Administration (FDA) are met.”
“Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively,” it said.
Emergent said it was committed to working with the FDA and J&J to fix the problems.
“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,” it said in a statement.
Robert Califf, the former commissioner of the FDA under the Obama administration, said that while the issues at the Baltimore plant appear “distressing,” manufacturing problems do happen and are a reason why FDA oversight is so important.
“Supply chain and manufacturing is really a complicated set of issues, but that’s why you need an FDA and you need inspections, and it’s really a joint responsibility of the FDA and the companies themselves,” he told CNBC in a phone interview.
Earlier this month, the Biden administration put J&J in charge of the Baltimore plant after U.S. officials learned that Emergent, a contract manufacturer that had been making vaccines for J&J and AstraZeneca, mixed up ingredients for the two shots. Officials also stopped production of the AstraZeneca vaccine.
Pausing production of new materials is the latest setback for J&J. Last week, the FDA and the Centers for Disease Control and Prevention advised states to temporarily stop using J&J’s vaccine “out of an abundance of caution” after six women developed a rare but potentially life-threatening blood-clotting disorder that left one dead and one in critical condition. A key CDC panel is scheduled to meet Friday to make a recommendation on the use of the vaccine.
The FDA said Wednesday its actions on the Baltimore plant are unrelated to the ongoing evaluation of the blood-clotting cases.
Source: Business - cnbc.com
