Loading ...Drug Batch Tainted? Just Hit Delete and Ship It to the U.S.
In a lab in an Indian village during the height of monsoon season in 2011, a technician hit a delete button — a keystroke that would have consequences three years later.
The quality-control employee of Sun Pharmaceutical Industries Ltd. had run high-powered chemical analyses on a drug sample to check for impurities that day. A certain level of impurity means the whole batch is supposed to be thrown out.
That’s not what happened. Instead, the results of the failed tests were deleted, according to a previously undisclosed account detailed in a November 2013 FDA document obtained by Bloomberg News. The following day, workers used a sample from the same batch that passed the test. That result got entered, and the entire batch was declared clean and ready to ship abroad, eventually to be used by patients in the U.S. The FDA’s computer forensics experts eventually found 5,301 additional deleted results from chromatography tests at the facility.