- The FDA cited a vaccine factory run by Emergent BioSolutions in Baltimore this week.
- The FDA said the factory, which botched millions of
Johnson & Johnson COVID-19 doses last month, had unsanitary conditions. - FDA officials said the facility had peeling paint and "brown residue" on the walls.
A Baltimore factory that botched the production of 15 million doses of the Johnson & Johnson
In a report on the factory for Emergent BioSolutions published by the FDA on Wednesday, officials said the facility had peeling paint and "brown residue" on the walls.
The FDA said in a statement that conditions at a factory can "lead to quality issues during the manufacturing of a product."
"The FDA's inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality," the FDA said in a statement. "During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility's processes met our requirements and standards."
Johnson & Johnson said in a statement that it will ensure that all of the FDA's concerns are "addressed promptly and comprehensively."
"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," the company said.
Emergent BioSolutions paused its production of COVID-19 vaccines at the factory on Tuesday at the request of government regulators who are investigating the botched doses, the Baltimore Sun reported.
The manufacturing plant ruined 15 million Johnson & Johnson vaccine doses last month when an employee reportedly mixed up vaccine ingredients.
No COVID-19 vaccines from the plant have been distributed in the US, as the FDA has not authorized the factory to do so, though the plant has manufactured millions of doses.
"For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality," the FDA said in a statement.
Emergent BioSolutions said in a statement that it is "committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified."
"The FDA's feedback will help continue to improve and strengthen the supply chain for Johnson & Johnson's vaccine," the company said. "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."