Food and Drug Administration report describes concerning conditions at Baltimore site where manufacturing was halted
A US Food and Drug Administration inspection report found unsanitary conditions and other problems at a Baltimore manufacturing plant that ruined more than 15m doses of Johnson & Johnson coronavirus vaccine.
The FDA reported the plant operated by Emergent BioSolutions “is not maintained in a clean and sanitary condition”. The report says the paint on the plant’s walls were peeling in several areas and paint flecks were found on the floor.
The report also found brown residue on the walls and floors.
In late March, the drugmaker said it had found a problem with an ingredient used in the single-shot Covid vaccine at a production site in Baltimore, Maryland, and halted manufacturing there. The plant belongs to Emergent Biosolutions, one of more than 10 companies that Johnson & Johnson is using to speed up manufacturing.
FDA officials reviewed security camera footage from the plant to conduct the report. The footage from 27 January to 3 February showed workers failing to follow procedures to prevent cross-contamination in several instances.
The product components, containers and closures were not stored in a manner to prevent contamination, according to the FDA report.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” reads a statement from the FDA.
“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,” the report says.
The report also states that the equipment in the plant was not of adequate size to facilitate operations for its intended use or for cleaning.
“Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively,” says a statement by the drugmaker. “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.”
US health officials paused distribution of the Johnson & Johnson Covid-19vaccine as scientists investigated the potential link between rare cases of blood clots and their vaccine.
On Tuesday, the European Union recommended a warning should be added to the vaccine’s product information and stressed that the benefits of the shot outweighed its risks.
Use of the Johnson & Johnson vaccine is still on hold in the US, and the Centers for Disease Control and Prevention is expected to meet on Friday to discuss the pause.
