Foreign Facilities Get Details From US FDA On Avoiding ‘Refusal To Allow Inspection’ Violation

Guidance states regulatory violation of refusing to permit entry of FDA investigator to inspect or not permitting an inspection includes “statements, actions, and passive behaviors that prevent or delay us from scheduling or fully conducting an inspection.”

“Passive behaviors” are among the actions by food and dietary supplement manufacturers outside the US that count as refusing to allow Food and Drug Administration officials to inspect their facilities and can lead to holds on imports of their products.

In a guidance published on 20 October, the FDA explains its thinking on when agency officials are unlawfully prevented from...