FDA Warns Gilead Over Drug Plant Problems

Law360, New York (October 5, 2010, 4:51 PM EDT) -- The U.S. Food and Drug Administration has formally warned drugmaker Gilead Sciences Inc. about alleged sanitation problems at its San Dimas, Calif., plant, the agency revealed Tuesday.

A four-page letter the FDA released accuses Gilead of allowing a bevy of quality breakdowns at its San Dimas plant: Rooms through which open sterile drugs are transported were not up to code, critical areas were not properly monitored for microorganisms, equipment was not cleaned often enough and procedures to ensure that sterile drugs stay clean were too lax,...
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