FDA Stings Gilead For Manufacturing Violations

Law360, New York (May 3, 2013, 4:42 PM EDT) -- Gilead Sciences Inc. disclosed Thursday that U.S. Food and Drug Administration inspectors have formally notified the company of manufacturing problems at a California plant, apparently leading the agency to reject the company’s bid for expanded use of certain ingredients in its HIV medicine Stribild.

In an earnings call, company executives disclosed that an FDA preapproval inspection at the company’s facility in the Bay Area town of Foster City, Calif., turned up several problems, including deficiencies in test methods, instrument specifications and laboratory records. The FDA issued...
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