US FDA Takes A Scientific Look At Hot-Button Issue Of Unannounced Foreign Inspections
Executive Summary
As Congress beats the drums for surprise inspections abroad, the agency plans a statistically rigorous comparison of announced versus unannounced inspections. Meanwhile, as authorities shed COVID-19 precautions, FDA investigators flood back into the field domestically, with surge of foreign inspections to follow soon.
You may also be interested in...
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.”
Surprise US FDA Facility Inspections Resume In India
Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.
House Appropriators Continue Pressing US FDA To Conduct Surprise In-Person Inspections
The bill also would give the FDA expanded authority over nicotine products and create President Biden’s Advanced Research Projects Agency for Health.