By James Jardine
For many manufacturers, facility inspections by the U.S. Food and Drug Administration (FDA) can be very difficult, and findings over the course of an inspection can have significant consequences. Depending on the severity of the findings and the manufacturer’s response to findings, the agency can issue warning letters, consent decrees or fines and initiate injunctions, seizures and criminal prosecution.
With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario. This white paper identifies key steps that manufacturers, life science companies and other organizations operating in FDA-regulated environments should take before, during and after an FDA inspection to ensure a successful audit.