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| Vials labelled “COVID-19 Coronavirus Vaccine” and a sryinge |
The U.S. Food and Drug Administration (FDA) said it had completed its inspection of a U.S. plant that makes Johnson & Johnson’s COVID-19 vaccine and asked for remediation of issues including peeling paint and loose debris at the site.
Emergent Biosolutions Inc, which owns the plant, earlier this week said it would stop production of new drug material at the plant, while the FDA conducted an inspection of the facility.
The FDA’s inspection closeout report, also known as “FDA Form 483”, cited observations including failure to train personnel to avoid cross contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca. The FDA also said on Wednesday the building used for manufacturing the components of the two vaccines was not of suitable size and design to facilitate cleaning and maintenance.
The facility has not been authorized by the regulator to manufacture or distribute any of Johnson & Johnson’s COVID-19 vaccine or components and, to date, no vaccine manufactured at this plant has been distributed for use in the United States.
