A detail of Janssen Johnson & Johnson COVID-19 vaccine that is not currently being given out because it has been put on hold.
Allen J. Schaben | Los Angeles Times | Getty Images
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-paged 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 also noted that employees did not follow standard operating procedures in handling waste or vaccine manufacturing materials to ensure against contamination.
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.
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.
This is a developing story. Please check back for updates.