The U.S. Food and Drug Administration (FDA) said it had found problems including peeling paint and loose debris during inspections at a U.S. plant in Baltimore that makes Johnson & Johnson's COVID-19 vaccine and asked for remediation of the issues.
Emergent Biosolutions, which owns the plant, has been seeking regulatory authorization to make the J&J vaccine there. It stopped production at the plant recently, saying the FDA had asked it to do so after an inspection.
The FDA said its inspections were complete and in a report detailed a long list of problems to remediate, including failure to train personnel to avoid cross contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca, which had also been made at the site. Production of that vaccine, which is not yet approved in the United States, has also been stopped.
The inspection, carried out between April 12 and April 20, found the building was not of the suitable size or design to facilitate cleaning, maintenance or proper operations.
It described the wall as having a brown substance on it. The FDA also said the equipment used was not of adequate size for cleaning and maintenance.
Johnson & Johnson said it will exercise its oversight authority to ensure that all of the observations from the regulator are addressed promptly and comprehensively.
Emergent was not immediately available for comment.
No vaccine manufactured at this plant has been distributed for use in the United States.
(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru; Editing by Shinjini Ganguli and Caroline Humer) ((Manas.Mishra@thomsonreuters.com; www.twitter.com/Manasmishra24; within U.S. +1 646 223 8780, outside U.S. +91 806749 2709;))
