teva logo 88.
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Teva Pharmaceutical Industries on Thursday announced it has received a warning
letter from the US Food and Drug Administration about the FDA’s Current Good
Manufacturing Practices (cGMP) inspection of the company’s Jerusalem Oral Solid
Dosage manufacturing facility that took place in September.
president and CEO is Shlomo Yanai, said it has addressed the FDA’s observations
since its initial written response to the warning in October and “is working
diligently to resolve any outstanding FDA concerns listed in the warning
The FDA cited “significant violations” of cGMP related to
laboratory reporting and systems.
“These violations cause your drug
products to be adulterated...
in that the methods used in, or the
facilities or controls used for, their manufacture, processing, packing or
holding do not conform to, or are not operated or administered in conformity
with, cGMP,” the FDA said in the letter.
The FDA said Teva’s response in
October “lacks sufficient corrective actions.”
Teva said the warning
letter did not restrict production or shipment of the company’s products from
the OSD facility.
However, unless and until the company is able to
correct outstanding issues to the FDA’s satisfaction, the FDA may withhold
approval of pending drug applications listing the Jerusalem OSD
The FDA may also withhold permission to export products
manufactured at the facility into the US.
Commenting of the FDA warning,
Citi analyst John Boris said the Jerusalem OSD facility accounts for less than 3
percent of Teva’s estimated $16.3 billion sales in 2010, or about $480
“After reviewing the letter, we do not expect the deficiencies
to materially affect production or shipment from this facility,” he said. “We
note that the FDA is withholding Abbreviated New Drug Application (ANDA)
approvals associated with the Jerusalem facility until Teva resolves outstanding
The issue does not affect Teva’s ANDA for generic Zyprexa,
which is not manufactured at the Jerusalem facility, Boris said.
said any weakness created by this issue it viewed as an enhanced buying
opportunity in Teva.