The wild and crazy world of uninspected pharmaceutical plants
You know the 5-second rule? That if you drop food on the floor, you can pick it up within 5 seconds and still eat it? I wonder if the five-second rule is in effect at drug manufacturing plants.
If you drop a batch of pills on the floor, all that you can scoop up in five seconds are still usable.
I wouldn’t be surprised.
As I told you last week, we’ve recently been given a peek behind the curtain at two very ugly pill mills. One was a contaminated and mismanaged Johnson & Johnson plant, closed down last May. The other was a GlaxoSmithKline plant in Puerto Rico that was described as “rife with contamination” for years.
So with drug manufacturing plants located all over the world, what do you suppose the chance is that dozens, maybe hundreds of these plants are as pristine as a Times Square hot dog stand?
I’m going to guess: pretty good chance!
A U.S. General Accountability Office report reveals that the FDA is seriously dropping the ball in domestic and overseas drug plant inspections.
When GAO officials examined a list of FDA priority inspection sites in foreign countries, they estimated that just a little more than 10 percent were inspected in 2009. At that rate, the GAO estimated that it would take nine years to inspect the remaining sites on the list.
Also, out of more than 3,750 sites, the GAO estimated that nearly 2,400 had never been inspected at all. Most of those sites are in China and India.
Just imagine what might be going on at all those sites.
On second thought, maybe we better not imagine.
Source:
“FDA Fails to Inspect Foreign Plants Sufficiently: GAO” Ed Silverman, Pharmalaot, 11/1/10, pharmalot.com
