Human and Animal Food Products from Foreign Establishments Refusing FDA Inspection

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 09/24/2024 updates the name of the Import Alert, the Reason for Alert and Guidance section. Changes to the import alert are bracketed by asterisks (***). As part of FDA's activities to protect the health and safety of US consumers, FDA often conducts establishment inspections of foreign 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 manufacturer and schedule an establishment inspection. Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin. The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspection personnel, combined with other evidence, ***establishes*** an appearance that the firm's products are man

Quoted from the “Reason for Alert” section of the FDA page for 99-32, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.