FDA (U.S. Food and Drug Administration) certification is mandatory for companies exporting food, drugs, medical devices, and cosmetics to the USA. It ensures products are safe, effective, and correctly labeled.
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Facilities that manufacture, process, pack, or hold food, drugs, or medical devices for consumption in the United States must register with the FDA. This is a legal requirement under the Bioterrorism Act of 2002 and FSMA.
Essential for clearing US Customs. Without FDA registration, your goods will be detained at the port of entry.
FDA approval is considered a gold standard globally, boosting your product's reputation in other international markets.
Demonstrates that your products meet stringent US safety and efficacy standards, protecting public health.
Proper registration and Prior Notice filing prevent costly delays and refusals of shipments.
Appoint a US Agent who resides or maintains a place of business in the US.
Obtain a DUNS number for your facility if you don't have one.
Submit registration details on the FDA Unified Registration and Listing Systems (FURLS).
Receive the 11-digit FDA Registration Number upon successful verification.
We provide a dedicated Startup Advisor, monthly compliance status reports, and ensure 100% accurate filing at the lowest fees in the market.
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