Shamkris Global Group

FDA License for Import Products

What is FDA License for Import Products?

All imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products.  The FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA Import Process

FDA-regulated products imported into the U.S. must comply with the same FDA laws and regulations that apply to domestic products. Entries are submitted to U.S. Customs and Border Protection (CBP) which then refers entries of FDA regulated products to FDA for review.

  • Products considered higher-risk and entry submissions with incomplete or inaccurate information are flagged for manual review by FDA to determine the admissibility of the product.
  • FDA’s screening tool uses various sources of information to assess risk; for example, a firm’s previous compliance history or known compliance problems with a certain product.
  • FDA’s entry reviewers use various sources of information to determine admissibility; for example, using FDA’s registration database to verify whether a declared manufacturer of a drug or medical device product complies with facility registration requirements.
  • FDA entry reviewers look for complete and accurate data in the entry submissions. Providing FDA with complete and accurate data expedites the review of your entry.
  • Imported items should not be distributed into commerce until FDA has determined admissibility.

Why this License is Required?

In order to make sure that food from the local market is hygienic, the Food and Drug Administration (FDAMaharashtra will soon be issuing a notice to vendors in local markets to obtain a food safety license from the authority.  Everybody who is dealing with food needs to have registration or license with us.

Who can get FDA Import License?

Drug Products

Medical Devices


Color Additives



Dietary Supplements

Labeling Products

Document Required for FDA Import License

Role of Shamkris and Process of FDA Import License

Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.

The License process described below:

Advisory for the document required

Preparation of documents as per application & list of documents.

Application File

Inspection by the department if required

Liason department

License issued

Applicable for 3 Years

Renewal when due

Who can issue the FDA Import License?


FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured

Importers can import foods into the United States without prior sanction by FDA, as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA.
It allows an individual or business to clear goods through customs and to make international payments for imported and exported goods.