FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

The numbers are pretty startling. It seems as though the FDA doesn't inspect domestic drug plants too often, but worse, they inspect foreign plants even less. Get the complete details in this Chicago Tribune news article, "FDA scrutiny of foreign drug plants knocked - GAO report finds huge gap in inspections." Here are some quick highlights . . .

1. Pharmaceutical factories in the U.S. get a federal inspection every 2.7 years, on average
2. It would take U.S. inspectors 13 years to visit each of the 3,249 foreign manufacturing plants that make medications for the American market
3. The GAO (Government Accountability Office) recommended more surveillance inspections of foreign plants

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Pharmaceutical Site Closings - Shocking Statistics

This Pharmalot blog posting by Ed Silverman is eye-opening to me, "And The Next Pharma Plant To Close Will Be . . ." The blog states, "Since January 2007, a total of 77 industry sites employing more than 14,000 people were either closed or have been put on notice, according to Industrial Info Resources, a research firm." Here's what I take away. Some plants could easily re-open in a matter of weeks. Others, "are tainted by the very factors that targeted them for closure. Aging facilities and equipment coupled with stringent FDA regulations place a particular burden on reopening the doors anytime soon." Bottomline, if your company is acquiring one of these plants, you'll want to know if there were pre-existing FDA GMP issues. Good luck if you are a prospective successor. 

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