FILE PHOTO: Vials labelled “COVID-19 Coronavirus Vaccine” and sryinge are seen in front of displayed Johnson&Johnson logo in this illustration taken, February 9, 2021. REUTERS/Dado Ruvic/Illustration
April 21, 2021
By Carl O’Donnell and Manas Mishra
(Reuters) – A plant making Johnson & Johnson’s COVID-19 vaccine must fix a long list of problems including peeling paint, poor sanitation and brown and black substances on surfaces, the U.S. Food and Drug Administration said in a 12-page report on the facility, which has paused manufacturing.
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.
Johnson & Johnson reiterated on Wednesday it was working to establish a global supply chain in which 10 manufacturing sites would be involved in the production of its COVID-19 vaccine, in addition to its plant in Leiden, the Netherlands.
The FDA said its inspections were complete and the agency issued a report that 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 produced at the site.
Emergent was not immediately available for comment.
Production of the AstraZeneca vaccine, which is not yet authorized for use in the United States, was previously stopped at the Emergent plant after ingredients from that shot contaminated a batch J&J vaccine, ruining millions of doses.
The FDA also noted that Emergent did not produce adequate reports showing that the vaccine it was producing met quality standards.
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 a wall as having a brown substance on it. The FDA also said the equipment used was not of adequate size for proper cleaning and maintenance.
The FDA report cited security camera footage of production staff carrying unsealed bags of medical waste around the facility, bringing it into contact with containers of material used in manufacturing.
Employees also failed to consistently log required showering and gown removal when going in and out of the sterile manufacturing space.
J&J said it will exercise its oversight authority to ensure that all of the observations from the regulator are addressed promptly and comprehensively.
The healthcare company said it was redoubling its efforts to get authorization for the facility as quickly as possible but did not provide a timeline for when it could resume operations.
No vaccine manufactured at this plant has been distributed for use in the United States.
(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru; Carl O’Donnell in New Yor; Editing by Caroline Humer, Peter Henderson and Bill Berkrot)