A plant manufacturing the Johnson & Johnson COVID-19 vaccine (JNJ.N) has to solve a long list of problems, including peeling paint, poor sanitation and brown and black substances on surfaces, the Administration reported. US Food and Drugs facility, which has stopped manufacturing.
Emergent Biosolutions (EBS.N), owner of the plant, has been requesting regulatory authorization to make the J&J vaccine. He recently stopped production at the plant, saying the FDA had asked him to do so after an inspection.
Johnson & Johnson reiterated Wednesday that it was working to establish a global supply chain in which 10 manufacturing centers would participate 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 detailing a long list of issues to be addressed, including lack of staff training to prevent cross-contamination of Johnson & Johnson’s COVID-19 vaccines. (JNJ.N) and AstraZeneca (AZN) .L), which had also occurred 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 halted at the Emergent plant after ingredients from the 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 produced met quality standards.
The inspection, which took place between April 12 and 20, found that the building was not the right size or design to facilitate proper cleaning, maintenance or operations.
He described a wall as a brown substance. The FDA also said the equipment used was not the right size for proper cleaning and maintenance.
The FDA report cited images from security cameras of production personnel carrying unsealed medical waste bags around the facility, putting them in contact with containers of material used in manufacturing.
Employees were also unable to consistently record the shower and dressing gown removal when entering and leaving the sterile manufacturing space.
J&J said it will exercise its oversight authority to ensure all regulator observations are addressed quickly and comprehensively.
The healthcare company said it was redoubled its efforts to get permission for the installation as soon as possible, but did not provide a timeline for when operations could resume.
No vaccine manufactured at this plant has been distributed for use in the United States.
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