|
 Israel-based Teva did not specify what issues were raised by the
FDA.
Bloomberg reported that the production halt followed Teva's recall
of more than 2.5 million vials of drugs in recent months, many of
them cancer medications. The report said the vials may have been
contaminated with mold owing to water leaks discovered by FDA
inspectors.
Teva said the plant received an FDA Form 483, which lists
observations of issues that could lead to potential FDA rule
violations.
"We have carefully reviewed the 483 and are taking extensive actions
to ensure the agency’s observations are fully addressed," Teva told
Reuters.
"As a precautionary measure, we temporarily stopped the manufacture
of products from the Irvine facility while we conduct a thorough
review."
Teva said all its facilities had strict and comprehensive quality
protocols in place and as part of the work it was doing in response
to the recent FDA inspection "we will further enhance our efforts to
ensure that we meet or exceed all regulatory requirements."
[to top of second column] |
 It noted that in an effort to
minimise impact on patients, it was working with
the FDA Drug Shortage Staff and FDA Office of
Manufacturing Quality while it conducts its
review.
"We will ensure that the agency and relevant
customers are aware of our progress as we move
forward," Teva said.
The Irvine plant - Teva Parenteral Medicines
Inc. - has faced similar problems in the past,
receiving an FDA warning about manufacturing
violations related to the production of sedative
propofol during a July 2009 inspection.
Teva's New York-listed shares were up 0.7% at
$9.77 in morning trading.
(Reporting by Steven ScheerEditing by David
Goodman and Mark Potter
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