10/29/2015

Why the FDA Is Worried About Chinese Drugs in Your Medicine Cabinet

  • Inspections find deleted data, altered quality test records
  • Chinese companies supply ingredients to top brand drugmakers
  • When FDA inspectors showed up at a Chinese company that supplies key ingredients to two of the U.S.’s biggest drug companies, a curious thing happened.
    After lunch, they walked into a quality control lab on the second floor, where they saw a worker pull what looked like a memory stick from a computer and put it in the pocket of his lab coat. The inspectors asked to see what he’d taken.
    And then the man turned and ran.
    The U.S. Food and Drug Administration inspectors at Zhejiang Hisun Pharmaceutical Co. never found out what the worker took from the computer, but they found plenty of other things, according to agency documents describing problems at the company, obtained through a Freedom of Information Act request by Bloomberg. There was evidence that quality control staff deleted records of tests that might show a drug was impure. Audit trails disappeared. A paper shredder was kept close by machines that recorded quality data.  Read more

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