Inspections by the US Food and Drug Administration (FDA) are not new to regulated industries and laboratories, as are compliance, enforcement, and criminal investigations. With the goal of addressing and minimizing significant health risks, an FDA inspection can either make or break a company, making a good and lasting impression or tarnishing its image, costing the company time, money, and business. For pharmaceuticals, laboratories, biotech leaders, and drug companies, proving quality systems is paramount.
Access to FDA guidelines and regulations is only the beginning. To achieve a five-star rating, pharmaceutical industry manufacturers and suppliers need to understand what FDA inspectors are looking for and how to respond to enforcement measures in a timely and effective manner.