Description:

Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) has increased access to records during routine inspections of manufacturing facilities. This is a significant development and, like any major change, it has raised questions and created confusion regarding compliance with such inspections.

This guidance was created to assist in-house counsel and other personnel responsible for regulatory compliance in understanding what records companies must make available to FDA investigators during a routine inspection. It also highlights gray areas of records access created by FSMA, notes frequent requests GMA members have received from investigators, and offers practical advice and considerations for navigating these issues.