FDA Banned Sun Pharmaceutical Industries Ltd Drug Plant After Finding Data Flaws, Rat Traps
Published: Apr 25, 2014
US regulators who visited a Sun Pharmaceutical Industries Ltd drug plant in India before the facility was banned last month from exporting to the US saw testing flaws, a garbage pileup, and a laboratory they called un-cleanable. The Food and Drug Administration (FDA) inspectors observed that some workers misrepresented test data and deleted undesirable results, according to an inspection report known as Form 483 that Bloomberg obtained via a Freedom of Information Act request. There were rodent traps and a strong smell of urine in a quality-control lab area and bathrooms were in total disrepair, with what appeared to be human waste on a wall, the report said.
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