FDA: Multiple Violations Found at Baltimore Plant Making COVID-19 Vaccines

WEDNESDAY, April 21, 2021 -- Improper disinfection and not following contamination prevention protocols are among the nine violations found by U.S. Food and Drug Administration inspectors at a Baltimore plant that had to discard up to 15 million doses of the Johnson & Johnson COVID-19 vaccine and was ordered to temporarily halt all production.

The inspection at the Emergent BioSolutions plant -- a subcontractor of Johnson & Johnson -- was conducted after reports that workers had contaminated a batch of Johnson & Johnson vaccine doses with the harmless virus used to deliver the AstraZeneca vaccine, which is also made at the plant.

The violations included: not properly disinfecting the factory and its equipment, not following procedures meant to prevent contamination of doses and to ensure the strength and purity of the vaccines made at the plant, improperly trained employees, and problems with the design of the building, according to the inspection completed Tuesday.

The FDA said it has not authorized Emergent to distribute any Johnson & Johnson vaccine doses and that no vaccine made at the plant has been released for use in the United States.

The agency said it was working with Emergent to fix the problems. Earlier this month, the FDA said the AstraZeneca vaccine could no longer be made at the plant to reduce the risk for cross-contamination with the Johnson & Johnson vaccine.

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Posted: April 2021