Creating Efficiency in Foreign Facility Inspections Act

S 1134, the Creating Efficiency in Foreign Facility Inspections Act, changes how the U.S. Food and Drug Administration (FDA) conducts drug facility inspections outside the United States. It requires the FDA to generally avoid notifying foreign drug manufacturers in advance of inspections, unless required by the host country's law or needed to protect public health. The bill also limits advance notice to the minimum necessary time and requires manufacturers to waive host country advance-notice requirements if they prevent inspections. This directly affects FDA inspection practices and foreign drug manufacturers operating in countries with inspection notification laws. The changes apply to routine surveillance inspections but exclude preapproval or for-cause inspections.