Indian companies exporting FDA-regulated products to the United States must register with the US Food and Drug Administration. Food facilities register and renew every two years and must appoint a US agent; drug and device establishments register and list products; cosmetics facilities register under MoCRA. Food shipments also require prior notice before arrival.
Registration by product
| Product | Requirement |
|---|---|
| Food | Facility registration, US agent, prior notice, FSMA compliance |
| Drugs | Establishment registration, drug listing, NDC |
| Medical devices | Establishment registration, listing, 510(k) where required |
| Cosmetics | Facility registration and product listing under MoCRA |
Process
- Appoint a US agent.
- Register the facility online.
- List products where required.
- Prepare for inspections and compliance.
FSMA for food exporters
Preventive controls, supplier verification and labelling compliance apply to food exporters.
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Get expert help →Common pitfalls
- Missing biennial renewal
- Non-compliant labels
- Inadequate documentation for inspections
Frequently asked questions
Is FDA registration the same as FDA approval?
No. Registration lists your facility; approval is a separate process for certain products like new drugs.
Is there a fee for food facility registration?
FDA does not charge for food facility registration, though service providers and US agents charge fees.
What happens if registration lapses?
Shipments can be refused or detained at US ports.
Do spices exporters need FDA registration?
Yes. Spices are food and their facilities must register.
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