Abstract
An independent panel of quality assurance professionals evaluated the U.S. Food and Drug Administration's FD483 forms. FD483 forms are used during laboratory site visits to document adverse findings. Findings were ranked for severity and identified as specific deviations from the good laboratory practice regulations. No trends were observed in the number or severity of the FD483 findings over a 7 year period. There was, however, considerable year-to-year variability in the types of facilities inspected and in the kinds of GLP deviations observed. Only 4% of the FD483s were judged as having an overall severity that would likely result in a disqualified study. The few academic and government laboratories that were evaluated generally fared poorly. A total of 225 FD483s were issued to 137 different laboratories. Of the 225 FD483s issued, 65% were issued to only 58 facilities during the initial and subsequent site visits.
The general conclusion is that more detailed information and a longer time frame are needed to observe trends in GLP compliance for different types of facilities and subsections of the GLPs. To allow a fair appraisal of the GLP compliance effort, research is needed to develop new and more consistent auditing methods that measure successful remedial actions and that provide testing facilities with information on how FD483 findings translate into GLP deviations and how deviations are ranked for severity.