Processing Magazine

FDA Issues Warning to Gilead Sciences over Quality Controls

October 5, 2010
According to the Associated Press, federal health regulators are warning biotech drugmaker Gilead Sciences Inc. about quality control violations at a California manufacturing plant. The Food and Drug Administration posted a warning letter on its website, outlining more than a half-dozen problems uncovered by inspectors on a routine visit to Gilead''s San Dimas, Calif.-based facility. The letter states that Gilead does not have written procedures to prevent bacterial contamination of its drugs. The inspectors also note that Gilead repeatedly failed to investigate batches of pills that "failed visual inspection." In addition, they say the company did not clean or properly maintain equipment. FDA inspectors visited the plant early in the year, and Gilead responded to those critiques in March. But the FDA states that the firm''s response "lacks sufficient corrective actions." The FDA is asking the company to update the agency on the corrective steps it is taking within 15 days of receiving the letter.