An installation producing the COVID-19 vaccine from Johnson & Johnson (JNJ.N) should solve a long list of problems, including paint, poor sanitation and brown and black substances on surfaces, the U.S. Food and Drug Administration said in a twelve-page report said the plant, which interrupted production.
Emergent Biosolutions (EBS.N), which owns the plant, has sought government authorization to make the J&J vaccine there. It recently halted production at the factory, saying the FDA had asked it to do so after an inspection.
Johnson & Johnson reiterated on Wednesday that they are working on establishing a global supply chain in which ten manufacturing sites will be involved in the production of its COVID-19 vaccine, in addition to its plant in Leiden, the Netherlands.
The FDA said its inspections had been completed and that the agency had issued a report outlining a long list of problems, including the failure to train staff to cross-contaminate COVID-19 vaccines from Johnson & Johnson (JNJ). N) and AstraZeneca (AZN). .L), which was also produced on the website.
Emergent was not immediately available for comment.
Production of the AstraZeneca vaccine, which has not yet been approved for use in the United States, was previously halted at the Emergent plant after components of the shot contaminated a group of J&J vaccines, destroying millions of doses. .
The FDA also noted that Emergent did not produce adequate reports showing that the vaccine it produces meets quality standards.
The inspection, which was conducted between April 12 and April 20, found that the building was not of the appropriate size or design to facilitate cleaning, maintenance or proper work.
It depicts a wall with a brown fabric. The FDA also stated that the equipment used was not of sufficient size for proper cleaning and maintenance.
The FDA report quoted security camera footage of production personnel carrying unsealed bags of medical waste around the facility, bringing it into contact with containers of materials used in manufacturing.
Employees also did not consistently record the required shower and gown removal as they entered the sterile manufacturing space.
J&J said it would exercise its supervisory authority to ensure that all the regulator’s comments are addressed promptly and comprehensively.
The healthcare company said it was doubling its efforts to get the facility authorized as soon as possible, but did not provide a timeline for when it could start again.
No vaccine manufactured in this factory is distributed for use in the United States.
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