FDA INSPECTIONS - A PRACTICAL CORPORATE RESPONSE

Effectively managing interactions with employees of the Food and Drug Administration (FDA) during agency inspections should be a goal of all FDA-regulated companies. The variety of issues that may arise during such inspections preclude formulating procedures that address all eventualities. Many matters, however, may be foreseen and companies are well advised to adopt policies and procedures, and to instruct employees as to these. Difficult matters relating to the scope of record requests and employee interviews challenge companies to balance statutory considerations with practical concerns relating to possible corporate exposure. This article discusses relevant considerations associated with FDA inspections as well as product recalls.