US Food and Drug Administration

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[4] and veterinary products.

FDA Registration

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).

US FDA Agent

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. Liberty Management Group Ltd provide US FDA Agent service to foreign food, drug, API and medical device establishments.

FDA Registration Number

The US FDA will assign a unique registration number to each registered food facility, the assignment of FDA registration number does not denote the approval of your establishment or product by the US FDA. The FDA registration number only recognizes that, your establishment is registered with US FDA. Any representation of FDA registration number on product labels or labeling which creates an impression of US FDA approval may cause misbranding of the product.

FDA Registration Certificate

US FDA is not issuing a registration certificate nor does US FDA recognize a registration certificate issued by private business. As your US FDA agent, Liberty Management Group Ltd. will verify the registration and issue FDA registration certificate for your records. The certificate of registration issued by LMG will help to make sure the registration process is complete and registration number is valid. LMG is also issuing Label compliance certificate for the products after carefully reviewing each product label. Compliance certificate issued by LMG will help you and your clients to assure your product labels are complying with FDA regulations and will help to avoid FDA detention at the port. You and your customers can verify the certificate details on our website by entering certificate number.

Corporate Mitra provides support to get USFDA registration and licenses all over India.

Documents Required For US FDA

The documents that would be required are as follows:

- Application form.

- Valid license to operate from the FDA.

- Product labels. You must provide copies of the product’s labels in all packaging sizes.

- Product documents.

- Certificate of analysis.

- Product sample.