Device GMP violation rate continues downward trend, dropping to 20% in FY 1995.
This article was originally published in The Gray Sheet
Executive SummaryDEVICE GMP INSPECTION VIOLATION RATE DROPS TO 20% IN FY 1995, Marge Hoban, chief of the Field Programs Branch within FDA Center for Devices and Radiological Health's Office of Compliance, reported May 7 at a Regulatory Affairs Professionals Society meeting in Rockville, Maryland. Of 1,662 GMP inspections conducted by FDA in fiscal year 1995, 20% (340) were found to be violative, continuing a three-year decline in the percentage of violative GMP inspections. In FY 1994, 23% of the 1,942 GMP inspections found violations, compared to 24% of inspections in FY 1993 and 26% in FY 1992.
You may also be interested in...
A collaboration between Novo and Fauna will look at animal hibernation and genetic sequencing for hints toward novel therapies for obesity. Pfizer will use Insilico’s machine learning technology in target validation.