A detail of the Janssen Johnson & Johnson COVID-19 vaccine that is currently not being given because it has been suspended.
Allen J. Paneroles | Los Angeles Times | Getty Images
The Food and Drug Administration said Wednesday that a Baltimore plant that ruined millions of doses of Johnson & Johnson Covid-19 vaccine was not sanitary and was not suitable for making injections.
The FDA has asked Emergent BioSolutions, which runs the plant, to temporarily stop producing materials for Covid-19 vaccines earlier this month, as the U.S. agency began an inspection.
“The firm has failed to adequately train personnel involved in manufacturing operations, sampling quality control, weighing and dispensing, and engineering operations to prevent cross-contamination of bulk pharmaceuticals,” FDA researchers wrote in the report.
The inspection, which was carried out earlier this month over a period of eight days, revealed a number of alarming quality problems found throughout the facility.
In a 13-page report, inspectors wrote that the facility used to make the vaccine “was not kept clean and sanitary” and “did not have the proper size, design and location to facilitate cleaning, the proper maintenance and operations “. “
FDA inspectors also noted that employees did not follow standard operating procedures in handling waste or vaccine-making materials to ensure contamination.
The FDA has not authorized the facility to manufacture or distribute Johnson & Johnson’s Covid-19 vaccine and none of the doses manufactured at this plant have been distributed for use in the United States.
The Biden administration put J&J at the helm of the Baltimore plant after U.S. officials learned that Emergent, a contract manufacturer that had been making vaccines against J&J and AstraZeneca, was mixing ingredients for the two shots. Officials also stopped production of the AstraZeneca vaccine.
This is a developing story. Please check for updates again.