FDA can place products on import alert, triggering detention without physical examination (DWPE) for shipments from non-compliant facilities or products with prior violations. Importers must work with FDA to resolve underlying compliance issues and may need to provide evidence of corrective action before shipments are released.

Foreign drug manufacturers must register with FDA under the Drug Supply Chain Security Act (DSCSA) and applicable regulations. Shipments from unregistered facilities are subject to refusal of admission, making facility registration status a critical pre-import verification step for trade professionals.