Part 2, conducting the audit - ready or not, here they come

A Food and Drug Administration (FDA) inspection can be a nightmare that can cost a company's money, time, and reputation, or it can be an opportunity to understand the logic behind FDA regulations and to prepare accordingly. Lavian and Allen present several pointers to remind managers of the preparation needed for inspections, whether the inspections are from the FDA, a client, an investor, or European agency.