Gilead Sciences Resolves U.S. Food and Drug Administration Warning Letter Related to San Dimas Manufacturing Facility
August 10 2011 - 5:01PM
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.
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