August 17, 2022

A detail of Janssen Johnson & Johnson’s COVID-19 vaccine that is not currently being issued because it has been on hold.

Allen J. Cockroaches | Los Angeles Times | Getty Images

The Food and Drug Administration said Wednesday a facility in Baltimore that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable for making the shots.

The FDA asked Emergent BioSolutions, which operates the facility, to temporarily suspend production of materials for Covid-19 vaccines earlier this month as the U.S. agency initiated an inspection.

“The company has not adequately trained personnel involved in manufacturing operations, quality control sampling, weighing and dispensing, and engineering operations to prevent drug cross-contamination,” FDA investigators wrote in the report.

The eight-day inspection earlier this month revealed a number of alarming quality issues throughout the facility.

In a 13-page report, inspectors wrote that the facility used to manufacture the vaccine “was not kept in a clean and hygienic condition” and “was not of the appropriate size, design and location for cleaning, maintenance and to facilitate proper operation. “”

The FDA inspectors also found that when handling waste or materials used to make vaccines, employees did not follow standard operating procedures to avoid contamination.

The facility has not been approved by the FDA to manufacture or distribute Johnson & Johnson’s Covid-19 vaccine, and none of the doses manufactured at this facility have been marketed for use in the United States.

The Biden administration hired J&J to run the Baltimore facility after US officials learned that Emergent, a contract manufacturer that made vaccines for J&J and AstraZeneca, mixed the ingredients for the two shots. Officials also stopped production of the AstraZeneca vaccine.

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