FDA Banned Sun Plant After Finding Data Flaws, Rat Traps

U.S. regulators who visited a Sun Pharmaceutical Industries Ltd. drug plant in India before the facility was banned last month from exporting to the U.S. saw testing flaws, a garbage pileup, and a laboratory they called “un-cleanable.”

The Food and Drug Administration 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.