Register with the U.S. Food and Drug Administration (FDA)
Unless otherwise exempt, the following types of establishments must register with U.S. Food and Drug Administration:
- Food Facilities that manufacture, process, pack, or store human or animal food for U.S. consumption.
- Medical Device and Radiation-Emitting Device (RED) Establishments that produce and distribute devices intended for use in the U.S.
- Drug Establishments that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S.
- Tobacco Establishments that manufacture, prepare, compound, or process tobacco products that are distributed in the U.S.
Additionally, Cosmetic Establishments may voluntarily register with FDA to take advantage of FDA’s secure database for back-up storage or to meet distributor requirements.
Registrar Corp will help you determine whether or not you must register with FDA and, if so, our Regulatory Specialists will register your facility with FDA quickly and properly. For more information, simply complete the form below: