A U.S. Food and Drug Administration inspection report discovered unsanitary conditions and other problems at a Baltimore facility that destroyed more than 15 million doses of Johnson & Johnson coronavirus vaccine.
The FDA reported that the Emergent BioSolutions plant is “not being maintained clean and hygienic”. The report says that paint on the walls of the factory was peeling in several places and paint stains 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 manufacturing site in Baltimore, Maryland, and discontinued production there. The plant is owned by Emergent Biosolutions, one of more than 10 companies Johnson & Johnson is using to accelerate production.
FDA officials viewed footage from the factory’s security cameras to execute the report. The images from January 27 to February 3 showed that in several cases employees did not follow procedures to avoid cross-contamination.
The product components, containers and closures were not stored in a way to prevent contamination, according to the FDA report.
“We will not allow a product to be released until we are sure it meets our expectations for quality,” said an FDA statement.
“The company has failed to adequately train personnel involved in manufacturing operations, quality control, sampling, weighing and dosing, and engineering activities to avoid cross-contamination,” the report said.
The report also states that the equipment at the factory was not of sufficient size to facilitate the work for its intended use or for cleaning.
“Johnson & Johnson will exercise its regulatory authority to ensure that all observations made by the FDA are promptly and completely addressed,” said a statement from the drug manufacturer. “The company will also redouble its efforts as it continues to work towards obtaining an emergency use license in the United States for medicines manufactured in Emergent Bayview as soon as possible so that the company can help end this global pandemic.”
US health officials paused distribution of the Johnson & Johnson Covid-19 vaccine as scientists investigated the possible link between rare cases of blood clots and their vaccine.
On Tuesday, the European Union recommended adding a warning to the vaccine’s product information, stressing that the benefits of the shot outweighed the risks.
Use of the Johnson & Johnson vaccine is still on hold in the US, and the Centers for Disease Control and Prevention are expected to meet Friday to discuss the hiatus.