FDA deems production site that ruined 15M doses of J&J vaccine 'unsanitary': Officials cite Emergent plant for walls and floors filthy with 'black and brown residue' and peeling paint
The plant responsible for ruining 15 million doses of Johnson & Johnson's COVID-19 vaccine has been branded filthy and unsanitary by the Food and Drug Administration (FDA).
Emergent BioSolutions, which owns the plant, must fix a long list of problems including peeling paint, poor sanitation and brown and black substances on surfaces, the FDA said in a 12-page report on the facility, which has paused manufacturing.
The company 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.
None of the doses made in the facility have been shipped to U.S. states. Distribution of J&J's sot is also paused amid fears it may cause dangerous blood clots, which the Centers for Disease Control and Prevention (CDC) and FDA are investigating.
FDA officials found dirty floors and walls with peeling paint at the Emergent BioSolutions facility that ruined 15 million doses of J&J vaccine. Emergent will have to fix the laundry list of issues in the 12-page report before it can get FDA clearance to produce vaccine (file)
No doses made at the plant have been shipped in the U.S. and distribution of the shot is paused amid blood clot concerns
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 FDA's 12-page report cited Emergent for not properly decontaminating the plant or stepping up cleaning practices after the ingredient mix-up last month
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 U.S.
Distribution of the J&J vaccine has been paused in the U.S. amid fears it may cause dangerous blood clots.
A vaccine advisory committee is expected to announce whether the pause should be lifted on Friday, and will likely give recommendations on which age groups and genders the the vaccine is safe for.
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