A plant that produces the Johnson & Johnson (JNJ.N) COVID-19 vaccine must solve a long list of problems, including peeling paint, poor hygiene and brown and black substances on surfaces, the US Food and Drug Administration said in a statement. 12-page report on the plant, which stopped production.
Emergent Biosolutions (EBS.N), which owns the factory, has applied for regulatory clearance to make the J&J vaccine there. He recently stopped production at the plant, saying the FDA had asked him to do so after an inspection.
Johnson & Johnson reiterated on Wednesday that it is working to establish a global supply chain in which 10 factories will be involved in the production of COVID-19 vaccine, in addition to the factory in Leiden, the Netherlands.
The FDA said its inspections were complete and the agency issued a report detailing a long list of remedial issues, including failure to train staff to avoid cross-contamination of Johnson & Johnson’s COVID-19 vaccines (JNJ.N ) and AstraZeneca (AZN). .L), which had also been produced on the spot.
Emergent was not immediately available for comment.
Production of the AstraZeneca vaccine, which is not yet licensed for use in the United States, was previously stopped at the Emergent plant after ingredients in that vaccine contaminated a batch of J&J vaccine, destroying 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, carried out between 12 April and 20 April, found that the building was not the right size or design to facilitate proper cleaning, maintenance or operation.
He described a wall as having a brown substance on it. The FDA also said that the equipment used does not have an adequate size for proper cleaning and maintenance.
The FDA report cited records from security cameras of production personnel carrying sealed bags of medical waste around the facility, bringing them into contact with material containers used in manufacturing.
Also, the employees failed to constantly record the necessary showers and the removal of the robes when entering and leaving the sterile manufacturing space.
J&J said it would exercise its supervisory authority to ensure that all comments from the regulator are addressed promptly and comprehensively.
The healthcare company said it was redoubled its efforts to obtain authorization for the facility as soon 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.
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