The FDA will begin routine inspections to verify compliance with the Intentional Adulteration (IA) rule in March 2020. Food facilities covered by the rule are required to implement and verify food defense plans that identify and mitigate vulnerabilities. The FSMA final rule on IA is designed to address hazards that may be intentionally introduced to foods, including acts of terrorism, with the intent to cause wide-spread harm to public health.

To help you prepare for these early inspections, we will provide an overview of the regulatory requirements, details on the three vulnerability assessment methodologies, and how to calculate public health impact based on FDA draft guidance. We will also discuss how the FDA may challenge businesses that use different methodologies and calculations. Within the discussion, we will cover best practices, actionable tips, and strategies to ensure both FDA and company expectations are met.