(Adds details from the report, JNJ statement)
April 21 (Reuters) - The U.S. Food and Drug Administration
(FDA) said it had found problems including peeling paint and
loose debris during inspections at a U.S. plant in Baltimore
that makes Johnson & Johnson's COVID-19 vaccine and
asked for remediation of the issues.
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.
The FDA said its inspections were complete and in a report
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 made at the site. Production of that
vaccine, which is not yet approved in the United States, has
also been stopped.
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 the wall as having a brown substance on it.
The FDA also said the equipment used was not of adequate size
for cleaning and maintenance.
Johnson & Johnson said it will exercise its oversight
authority to ensure that all of the observations from the
regulator are addressed promptly and comprehensively. (https://bit.ly/32wZMak)
Emergent was not immediately available for comment.
No vaccine manufactured at this plant has been distributed
for use in the United States.
(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru;
Editing by Shinjini Ganguli and Caroline Humer)