Failure to renew FDA registration can have adverse effects. In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.
FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration. Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed. It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.
