A detail of the Janssen Johnson & Johnson COVID-19 vaccine that is not currently given because it has been suspended.
Allen J. Beetles | Los Angeles Times | Getty Images
The Food and Drug Administration said Wednesday that a Baltimore plant that destroyed millions of doses of Johnson & Johnson Covid-19 vaccine is unhygienic and unsuitable for photography.
The FDA has asked Emergent BioSolutions, which runs the plant, to temporarily stop producing materials for Covid-19 vaccines earlier this month, while the US agency initiated an inspection.
“The company has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weighing and distribution, and engineering operations to prevent cross-contamination of bulk drugs,” FDA investigators wrote in the report. .
The inspection, which was carried out earlier this month over an 8-day period, revealed a number of alarming quality problems found throughout the unit.
In a 13-page report, inspectors wrote that the facility used to make the vaccine “was not kept in a clean and sanitary state” and “did not have adequate dimensions, design and location to facilitate proper cleaning, maintenance and 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 was not authorized by the FDA to produce or distribute Johnson & Johnson’s Covid-19 vaccine, and none of the doses manufactured at that plant were 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 makes vaccines for J&J and AstraZeneca, mixed ingredients for the two photos. Officials also stopped production of the AstraZeneca vaccine.
This is a developing story. Please check again for updates.