Handling FDA and state regulatory inspections has never been easy, but at least companies knew what records they had to share and how to deliver a uniform company message by using designated plant spokespeople.
With Food Safety Modernization Act (FSMA) implementation, this has changed. Now regulators review risk-based hazard analysis documentation and have access to plant food-safety records, including training records with planned interviews for plant personnel. All plant personnel participating in the inspection must be prepared to interact with regulators.