Teva reports FDA warning on facility

The FDA cited “significant violations” of cGMP related to laboratory reporting and systems.

By HILLEL KOREN
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.
Teva, whose 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 letter.”
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 facility.
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 million.
“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 cGMP issues.”
The issue does not affect Teva’s ANDA for generic Zyprexa, which is not manufactured at the Jerusalem facility, Boris said.
Citi said any weakness created by this issue it viewed as an enhanced buying opportunity in Teva.