FDA finds peeling paint, debris at US plant making J&J’s COVID vaccine

DM

A US plant that was making Johnson & Johnson’s COVID-19 vaccine must fix a long list of problems including peeling paint and unsanitary conditions and practices to resume operation, according to a highly critical report by the Food and Drug Administration. Experts said addressing the issues raised in the scathing FDA inspection report could take months. Neither J&J nor the FDA has said when they expect vaccine production to restart at the Baltimore plant owned by Emergent Biosolutions. Only two other plants are currently equipped to supply the world with the key drug substance for J&J’s vaccine. “It may take many months to make these changes,” said Prashant Yadav, a global health care supply chain expert at the Center for Global Development. He described some of the issues raised by the FDA as “quite significant.” No vaccine manufactured at the Emergent plant has been distributed for use in the United States. However, J&J said it will exercise its oversight authority to ensure that all of the FDA observations are addressed promptly and comprehensively.

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