FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
by Megan Rose and Debbie Cenziper
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U.S. inspectors have uncovered new and dangerous breakdowns in drugmaking at an Indian factory owned by Sun Pharma that produces generic medications for American consumers.
The latest problems come 2 1/2 years after the Food and Drug Administration gave the facility a special pass to continue sending certain drugs made there to the United States, even after the factory was officially banned from the U.S. market.
The factory failed to investigate the source of bacteria found in test vials or deal with damaged equipment that had caused drugs to be contaminated with metal particles, according to the June inspection report, which ProPublica obtained through a Freedom of Information Act request.
Workers improperly handled vials and stoppers meant for sterile medications and, in some cases, failed to disinfect manufacturing areas and equipment, according to the report. One FDA inspector saw a worker put on a sterile gown and then brush up against a waste bin and use their hands to push down the........
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