Tag: FDA medical device establishment registration

Introduction Entering or operating in the United States market requires more than product quality it demands precise regulatory compliance. For companies dealing in FDA-regulated products, US FDA establishment registration and database accuracy are fundamental compliance obligations that directly affect imports, inspections, and business continuity. The US FDA Establishment Registration Database is the FDA’s primary reference…

Introduction For companies manufacturing, processing, packing, or holding products regulated by the United States Food and Drug Administration (US FDA), establishment registration is not optional—it is a mandatory compliance requirement. Whether you are a food exporter, pharmaceutical manufacturer, cosmetic brand, medical device company, or dietary supplement business, your establishment must be properly registered and accurately…