Federal
regulators on Wednesday issued highly critical findings from their
inspection of a Baltimore plant that was forced to throw out up to 15
million doses of Johnson & Johnson’s coronavirus vaccine and ordered to temporarily stop all production.
The Food and Drug Administration cited a series of shortcomings at the massive plant, which is operated by Emergent BioSolutions.
The inspection was triggered by reports that Emergent workers had
contaminated a batch of Johnson & Johnson doses with the harmless
virus that is used to deliver AstraZeneca’s vaccine, which is also
manufactured at the plant.
The
violations included failure to properly disinfect the factory and its
equipment, as well as failure to institute and follow proper procedures
designed to prevent contamination of doses and to ensure the strength
and purity of the vaccine manufactured there. “There is no assurance
that other batches have not been contaminated,” the inspectors wrote.
Their 12-page report
cited nine violations, ranging from the design of the building to
improperly trained employees. The inspection was finished on Tuesday.
In a statement,
the F.D.A. noted that it has not authorized Emergent to distribute any
doses of Johnson & Johnson vaccine, and that no vaccine manufactured
at the plant has been released for use in the United States....
The
inspectors found that workers frequently moved between the
manufacturing zones without documenting that they had showered and
changed their gowns as required. In one ten-day period in February, for
instance, 13 employees moved from one zone to another on the same day,
but only one documented having showered, they said. After the Johnson
& Johnson doses were found to be contaminated, the report said, only
routine cleaning was performed.
Workers
also failed to properly handle manufacturing waste, creating risks of
contamination in the warehouse where raw materials are stored, the
inspectors found. They also cited peeling paint, crowded equipment and
other issues with the building. Overall, it “is not maintained in a
clean and sanitary condition,” they wrote.
Emergent
said in a statement on Wednesday that “while we are never satisfied to
see shortcomings in our manufacturing facilities or process, they are
correctable and we will take swift action to remedy them.”
In
its own statement, Johnson & Johnson said it had already stepped up
its oversight of Emergent, its subcontractor, and that it would “ensure
that all of F.D.A.’s observations are addressed promptly and
comprehensively.”
One major change has
already been made: AstraZeneca will no longer be manufactured at the
plant, a move that federal officials insisted upon earlier this month to
limit the chance of cross-contamination between two vaccines.
Dr.
Jose Romero, the Arkansas health secretary and chairman of the expert
panel advising the Centers for Disease Control and Prevention on the
future of the Johnson & Johnson vaccine, said in an interview that
he was dismayed by the F.D.A.’s findings. The panel is meeting on Friday
on whether to lift, modify or retain a pause in the administration of
Johnson & Johnson’s vaccine that was instituted last week for an
entirely different issue: the discovery that eight U.S. residents
developed a rare but dangerous blood clotting disorder after they got
shots.
“I’m shocked” Dr. Romero said.
“I can’t put it any other way. Inappropriate disinfection, the
prevention of contamination — those are significant and serious
violations, at least in my mind, and do of course need to be remedied.
“I
would not have expected that, given the stringency that we have in this
country for good manufacturing practices in these vaccine plants,” he
said.
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