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.
It usually starts with Form 483, which “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance.” (more…)