This white paper outlines the most common reasons the FDA has issued Form 483 Inspectional Observations since the beginning of FY 2016 through the present date and shows how an Enterprise Quality Management System (EQMS) can help pharmaceutical companies avoid running afoul of the FDA and other like-minded regulatory bodies.
The U.S. Food and Drug Administration (FDA) issues Form 483 Inspectional Observations or warning letters when communicating to a pharmaceutical company that its quality practices are not in compliance with regulatory standards. Most of these observations and warnings are due to some form of the following infractions:
No established procedures that conform to FDA standards in one or more regulated areas;
Established procedures conform to FDA standards, but are not followed according to regulations; or
Procedures conform to FDA regulations and are followed, but are inadequately documented and do not prove the organization is within compliance parameters.