18/01/2022 Other Services
Because hand sanitizers are considered over-the-counter (OTC) drug products, manufacturers, exporters, and importers must be registered as Drug Establishments with the FDA. Such registration requires the DUNS Number of each establishment. We also expect your company to provide an FDA compliant label, when contacting ITB HOLDINGS LLC.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
www.itbhdg.com
https://www.itbhdg.com/blog/importing-hand-sanitizers/
Entities that registered with the FDA during the Coronavirus Disease 2019 (COVID-19) pandemic, and whose sole activity with respect to OTC monograph d...
A DUNS Number is now required for all U.S. FDA Registrations: Food Facility, Food Canning Establishment, Cosmetic Establishment, Drug Establishment, M...
Unless exempt, all domestic and foreign facilities or establishments manufacturing, holding, exporting, importing and distributing FDA regulated produ...
The process includes FDA registration, compliance with GMP/QSR standards, submission of required applications (ANDA, 510(k), PMA), product testing, la...
More Details