Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 10/27/2021 updates the reason for alert section, guidance section including agency contacts, product description, charge section and PAC. Changes to the import alert are bracketed by asterisks (***). As part of FDAs activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections of foreign manufacturers that produce FDA-regulated articles intended for sale in the United States. As part of this inspection process, FDA may contact the foreign manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin. If a manufacturer that offers devices for import into the United States refuses to permit or allow the initiat

Quoted from the “Reason for Alert” section of the FDA page for 89-16, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.