Processing Magazine

FDA cites Abraxis for plant problems

February 19, 2007

Federal regulators warned drug maker Abraxis Bioscience Inc. that its manufacturing procedures do not safeguard its products from possible contamination, the Associated Press reports. The Food and Drug Administration told Abraxis in a December letter that it has not established procedures to guarantee sterilization of drugs made at an Illinois plant. As a result, the company is in violation of federally enforced manufacturing standards, according to the Dec. 18, 2006 letter. The warning letter tells Abraxis to send the agency a written plan for fixing the problems within 15 days of receiving the letter. The FDA did not place limits on the company''s ability to market products or submit new products for approval. Headquartered in Los Angeles, Abraxis specializes in making generic injectable drugs and posted annual revenue of $518 million in 2005. FDA staff uncovered the manufacturing problems during an inspection of the company''s Melrose Park, Ill., plant between May and June 2006. The agency''s investigators found that when contamination problems did arise at the plant, Abraxis'' workers did not uncover or record what caused the problem. In two cases where contaminated batches of drugs were found at the plant, company staff shipped the surrounding batches of drugs without verifying they were not also contaminated. The warning letter also said Abraxis does not have FDA-approved applications to market three of its injectable drugs.