FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API or medical device in the USA. FDA registration is not mandatory for cosmetic establishments but can participate in FDA voluntary cosmetic registration program (VCRP).

All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement and without US FDA Agent; the registration cannot be completed. Our Us Agent Will provide US FDA Agent service to foreign food, drug, API and medical device establishments.

All Drug, API and Medical Device establishments registered with FDA must renew their registration annually. FDA may consider the products of companies which are not complying with FDA renewal requirements as misbranded and may lead to FDA detention of your products.

FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. Any representation of FDA registration number on product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product.

FDA will not issue a registration certificate after completing the registration, also FDA will not recognize a third party registration certificate. Most Importers and Shipping companies always ask for FDA registration certificate or proof of FDA registration to the manufacturer. We will issue a certificate of FDA registration to our clients for their records by our USFDA Agent . Our clients and their customers can verify the certificate on our US Agent website.