Drugs From Foreign Establishments Refusing FDA Inspection

Why FDA issued it

NOTE: The revision of this Import Alert, dated 12/10/2024, updates the reason for alert section, Agency contacts, and includes additional guidance on exemptions covered under detention without physical examination. Changes are bracketed by asterisks (***). REASON FOR ALERT: As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections ***and remote regulatory assessments*** of foreign drug manufacturers who produce FDA-regulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may contact the foreign drug manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. ***Additionally FDA may conduct a mandatory remote regulatory assessment, such as a 704(a)(4) Records Request.*** Access to these facilities is a critical aspect of prote

Quoted from the “Reason for Alert” section of the FDA page for 66-79, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.