Last checked at 
(Adds additional detail from FDA report and company press
release)
By Carl O'Donnell and Manas Mishra
April 21 (Reuters) - A plant making Johnson & Johnson's
COVID-19 vaccine must fix a long list of problems
including peeling paint, poor sanitation and brown and black
substances on surfaces, the U.S. Food and Drug Administration
said in a 12-page report on the facility, which has paused
manufacturing.
Emergent Biosolutions, which owns the plant, 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.
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 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 United States.
(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru;
Carl O'Donnell in New Yor; Editing by Caroline Humer, Peter
Henderson and Bill Berkrot)
