There are two major types of drug inspections conducted by the FDA: (1) pre-approval inspections, which are oftentimes pre-announced; and (2) post-approval, or GMP inspections, which are almost always unannounced. Special, or directed, investigations are also conducted based on various triggers and they are seldom announced. The objective of a pre-approval inspection is twofold: (1) to find out whether what a firm said in its new drug application is accurate — to verify the application, and (2) to see if the firm has adequate controls in place to manufacture the new product consistently. In a post-approval inspection, we [FDA investigators] generally just show up at a firm’s door. The goal is to get a realistic look at the firm’s day-to-day operations — to assess the company’s ongoing compliance with the good manufacturing practice regulations. Based on a risk-based management approach, companies are “ranked” or categorized according to the degree of [public safety] risks that their products and processes pose. There is a weighted factor or a number that corresponds to a company’s risks. Those that fall under the “high risk” category will generally get inspected first. The whole point is for the FDA to match the level of its inspection efforts to the magnitude of a risk.
