The U.S. Food and Drug Administration (FDA) has published a new import alert category relating to facility inspections of importers.

The new import alert, "Detention Without Physical Examination of Products From Firms Refusing FDA Foreign Establishment Inspection" ("IA 99-32"), allows the FDA to refuse entry into the country any products that have come from a company that has declined to let the FDA inspect their manufacturing facility. All facilities dealing in FDA-regulated products are subject to inspection for current Good Manufacturing Practices, safety and sanitary conditions.


Any firm placed on IA 99-32 is charged under Section 801(a)(1) of the Federal Food, Drug and Cosmetic Act and can look forward to a lengthy process to get themselves off the Alert.

“The FDA Guidance for IA 99-32 clearly outlines the leaps and hurdles which will be necessary to be removed from the Alert,” said Benjamin England, founder of LLC. “Although these are only guidelines, meaning ‘tips and suggestions’, the FDA tends to treat them more like regulations and requirements.”