FDA inspectors get new tools

The FDA's border inspectors are getting a new computer system. Designed to help overloaded inspectors better target their work, the system will score products coming into the U.S. according to a.) the manufacturer's safety history and b.) the product's own susceptibility to contamination. That way, the riskiest shipments will be flagged, and inspectors can focus in on them.

Why is this significant? There have been several drug-import problems over the past several years, from the tainted-heparin snafu of 2008 to more recent issues with some generics deemed substandard by the FDA. Small wonder, given that the number of food-and-drug shipments into the U.S. has skyrocketed to about 20 million from 6 million a decade ago. These days, more than 40 percent of medicines come into the U.S. from abroad.

That's why there was such an outcry when, following the heparin contamination scare, folks discovered just how few inspectors are charged with screening drugs made overseas. At the time, computer systems were one of the weak points critics identified. We'll have to see how this new approach works.

- read the Reuters news 

Related Articles:
The Top 12 GMP Violations
FDA wants satellite offices overseas
Leavitt: We'll bar subs-par exporters