Tag: FDA establishment identifier
-
FDA Drug Establishment Registration: Practical Compliance Guide
U.S. Food and Drug Administration drug establishment registration is a foundational regulatory step for pharmaceutical companies aiming to enter or continue operations in the United States market. Any facility involved in drug manufacturing or related activities must be properly registered to ensure transparency, safety, and regulatory control within the U.S. drug supply chain. What Does…
-
US FDA Establishment Registration Database Compliance Services by XPRO America
Introduction For manufacturers, exporters, and brand owners targeting the United States, FDA compliance is not limited to product quality—it starts with accurate establishment registration. The US FDA Establishment Registration Database is the backbone of FDA oversight, import screening, and inspection planning. If your facility information is inaccurate, outdated, or improperly classified in the FDA database,…