The FDA report describes the Emergent vaccine plant as “overcrowded” and “crowded,” leading to stacks of different materials side by side and difficulty navigating the floor without colliding with equipment. Inspectors also noticed peeling paint on walls and floors and improper decontamination of waste in facilities.
Emergent said he is working with the FDA and J&J to resolve issues quickly. “Although we are never satisfied to see deficiencies in our facilities or manufacturing processes, they are correctable and we will take swift action to remedy them,” the company said in a statement.
He added that “the issuance of findings by the FDA is normal following an inspection of the facility and provides instructions on the steps required to improve operations.” But it is rare for the agency to move so quickly – issuing a report on an inspection completed just a day earlier – and to accompany its findings with a statement from senior FDA officials.
Johnson & Johnson relied on Emergent to reach its goal of delivering 100 million doses to the federal government by June, although production pressure has eased since the company’s vaccine was discontinued in the United States for a rare unrelated probe. , but severe blood clots. J&J has also turned to pharmaceutical giant Merck to help produce the vaccine, but the Merck production unit will not be ready to help until the second half of the year.
A second Merck plant on board to fill vials with the J&J vaccine and complete packaging doses is unlikely to begin production without deliveries of vaccine from Emergent, a person with knowledge of the situation said. The person and another familiar with the FDA process said it could take several months for some of these issues to be resolved.
In a statement, Johnson & Johnson said it will work to resolve the issues identified in the FDA inspection report and will continue to seek emergency authorization for Emergent, which will allow the company to manufacture the J&J vaccine.
But J&J also announced that it is setting up a “global vaccine supply network” that includes a production site in Leiden, the Netherlands, which already produces the Covid-19 vaccine, as well as ten additional production sites, nameless.
“We are working non-stop to generally develop and activate our production capacity to supply the COVID-19 vaccine worldwide,” the company said.
The FDA released its latest inspection report just a day after investors said they would sue Emergent for not previously revealing production issues that led to the ingredient mix that destroyed 15 million J&J photos. Federal regulators ordered AstraZeneca to leave the Emergent plant in March, citing production accidents.
The agency also inspected Emergent facilities in February and October, but it is unclear whether the scale of these problems was foreseen in previous reports.
The FDA “takes very seriously its responsibility to ensure the quality, safety and efficacy of medical products,” Acting Commissioner Janet Woodcock and head of the vaccine agency Peter Marks said in a joint statement. “The US public trusts the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and efficacy.”
The FDA, which said it is working with Emergent to resolve the issues, will need to re-inspect the plant and generally test batches before eliminating doses for release.
Woodcock and Marks said in their statement that all doses already manufactured are subject to additional testing, but have not yet been clear for release. Doses made by Emergent are not authorized for emergency use, so none have been used by the public.