July 2011 Posts

483s Can Be a Good Thing (Really)

Mark Crawford

According to FDANews, the increasing rate of FDA inspections and warning letters is continuing this year—as of June 2011 the FDA had issued 874 letters in fiscal 2011, compared with 673 last year. If FY 2011 is like 2010, leading issues will be quality unit deficiencies, inadequate batch failure investigations, lack of follow-up procedures, validation of manufacturing processes, and handling deviations. For international inspections, deficient laboratory controls, quality unit deficiencies, and deficient procedures led the list last year. (more…)

FDA Struggles with Rising Imports

Mark Crawford

It’s been a long time coming—overwhelmed by an ever-increasing flood of imported products that need be inspected, in June the FDA announced a plan to better address monitoring and regulating these goods. And, facing the stark realities of restricted funding, outdated technology, and sometimes less-than-willing global partners, it won’t be easy. (more…)