FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has resolved all outstanding issues raised in a Warning Letter issued by the U.S. Food and Drug Administration (FDA) in September 2010 related to its San Dimas, California manufacturing facility.
The FDA notified Gilead today that the company's response and the actions that have been adopted and implemented at the San Dimas site have sufficiently addressed the FDA's observations, which were primarily related to the manufacturing environment for AmBisome®(amphotericin B) liposome for injection, as well as general observations related to systems, procedures and controls focused on ensuring product quality at the San Dimas facility.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
AmBisome is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.