FDA (U.S. Food and Drug Administration Registration)

FDA Registration is a mandatory requirement for domestic and foreign facilities that manufacture, process, pack, or hold food, beverages, dietary supplements, drugs, or medical devices for consumption or use in the United States. It ensures that the facility complies with U.S. safety and quality standards, allowing the products to legally enter the American market.

It is required before your products reach a U.S. port of entry. Specifically:

• Food & Beverages: For any facility handling human or animal food (including spices, tea, and processed snacks).

• Medical Devices: For establishments involved in the production and distribution of medical devices (Class I, II, or III).

• Pharmaceuticals: For manufacturers, repackers, or re-labelers of drug products.

• Cosmetics: While registration was previously voluntary, the MoCRA (2022) now makes facility registration and product listing mandatory for most cosmetic manufacturers.

Required Documents

• Business Credentials: GST Certificate, Company PAN, and Certificate of Incorporation (CIN).

• DUNS Number: Confirmation of your Data Universal Numbering System registration.

• U.S. Agent Details: Name, address, and contact information of your authorized agent in the USA.

• Facility Details: Physical address of the manufacturing/processing plant and a list of activities performed there.

• Compliance Certificates: Proof of GMP (Good Manufacturing Practices), HACCP, or ISO certifications (often required for the application's technical side).

• Product Labels: High-quality copies of product labels that meet U.S. labeling requirements (nutrition facts, ingredients, etc.).