FDA Could Warn Gilead For Manufacturing Issues

Law360, New York (August 9, 2010, 2:40 PM EDT) -- Biopharmaceutical company Gilead Sciences Inc. could receive a warning letter from the U.S. Food and Drug Administration regarding manufacturing conditions at one of its California factories, the company disclosed in a regulatory filing Monday.

The company, which manufactures fungal treatment AmBisome and respiratory drug Cayston and fills and finishes macular degeneration drug Macugen at the San Dimas, Calif., facility, said the FDA conducted routine inspections of the plant in January and February.

The FDA found problems with the maintenance of aseptic processing conditions for AmBisome, environmental...
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