Assessing the FDA’s Safety DriveAugust 1, 2016 Download PDF
On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from a computer and put it in his pocket. When they asked what he had removed, the man ran away.
This article was published as an Op-Ed in BARRON’s Magazine in July 2016. Dow Jones Copyright.
- Mark I. Schwartz