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FDA warns Gilead on manufacturing plant
  Wed Sep 29, 2010 5:56pm EDT
* Gilead says working to resolve FDA concerns
LOS ANGELES, Sept 29 (Reuters) - The U.S. Food and Drug Administration has warned Gilead Sciences Inc about manufacturing problems at the San Dimas, California plant where drugs including the company's flagship HIV medicines are made.
Gilead, in a regulatory filing on Wednesday, said the warning letter from the agency is connected with an inspection of the facility that took place in January and February. Gilead said it responded in March to the FDA's observations.
The company said the letter details inadequacies including generalized concern over the effectiveness of the San Dimas quality unit in carrying out its responsibilities.
It also said it is "working diligently" to resolve any outstanding FDA concerns. "Unless and until we are able to correct outstanding issues to the FDA's satisfaction, the FDA may withhold permission to export AmBisome to certain countries outside the United States and Europe," Gilead said, referring to its antifungal drug.
The company said the FDA may also withhold approval of pending drug applications listing the San Dimas facility and the warning could impact Gilead's ability to supply aseptically packaged products manufactured at San Dimas (AmBisome, Cayston for cystic fibrosis, Macugen, an eye drug) outside the United States. But Gilead said it does not believe the letter will impact its ability to supply any of its solid dosage form products, including AIDS drugs Atripla, Emtriva, Truvada or Viread.
"In the event our solid dosage form products were affected, we have alternate sites from which we could supply such products," the company said. (Reporting by Deena Beasley; editing by Carol Bishopric)
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