Bill > S3509

This bill, titled the "Creating Efficiency in Foreign Facility Inspections Act," aims to strengthen the authority of the Food and Drug Administration (FDA) with respect to inspections of foreign drug facilities. The key provisions of the bill include: 1. Allowing the FDA to conduct unannounced inspections of foreign drug facilities, unless the law of the country where the facility is located mandates advanced notification or the FDA determines that advanced notification is needed to protect public health. 2. Requiring the FDA to minimize the time between any advanced notification and the actual inspection of a foreign facility. 3. Stating that if a country enacts a law that prevents the FDA from conducting inspections as outlined in the bill, the manufacturer must agree to waive any right to enforce the advanced-notice requirement, or the manufacturer will be deemed to have refused entry or inspection, which is a violation of the Federal Food, Drug, and Cosmetic Act. 4. Exempting preapproval, prelicensure, and for-cause inspections from the requirement of not notifying the foreign facility in advance.