Don’t Risk the Chance of an FDA ‘Bear Dance’
An inspection by the FDA can have consequences for a manufacturer, ranging from inconvenience to calamity. In the 1990s, then-Commissioner David A. Kessler strengthened the FDA field force and emphasized inspections. Increased regulatory action followed: In 1994, FDA issued 1,626 warning letters, initiated 98 seizure actions, obtained 16 injunctions against companies and initiated 8 criminal prosecutions. Many of these actions were based on information obtained by investigators during inspections.