FDA US Agent
US Agent designation for foreign establishments, receiving and relaying FDA correspondence.
Review scopeUS FDA market-entry compliance
Regulatory support for brands entering the United States.
A practical compliance desk for international companies handling FDA US Agent, food and supplement facility registration, MoCRA cosmetics, label review, and marketplace claim risk.
Positioning
The service is FDA compliance clarity, not brand theater.
The site is organized around regulatory workstreams. The operating company is KECC LLC, but the front door is the problem clients actually search for: US FDA compliance support for market entry.
Core services
Market-entry support by product and risk area.
Food and supplement facility registration
FDA registration and biennial renewal for foreign food and supplement facilities. The 2026 renewal window runs 1 October to 31 December.
Review scopeMoCRA cosmetics
Cosmetic facility registration and product listing, filed through FDA Cosmetics Direct.
Review scopeLabel review
Review of required label elements, claim language, and category-specific risk.
Review scopeAmazon compliance
Review marketplace claims, images, and product language that can trigger FDA-related risk.
Review scopeService matrix
What the compliance desk can handle.
| Service | Best for | Typical deliverable | Timeline | Bought separately | Fee |
|---|---|---|---|---|---|
| FDA US Agent (1 year) | Foreign facilities | Agent designation, FDA correspondence relayed | 1 business day | — | $299 |
| Food / supplement facility registration or renewal | Foreign food and supplement plants | FDA registration number or renewal confirmation | 3 business days | — | $299 |
| Registration + US Agent bundle | Plants entering the US for the first time | Registration number plus a full year of US Agent | 3 business days | $598 | $499 |
| US Market Entry Pack | First-time entrants with no DUNS number yet | D-U-N-S number, facility registration, a full year of US Agent | 3 business days after the number is issued | $747 | $649 |
| MoCRA cosmetic facility registration | Cosmetic manufacturers | Facility registration plus one product listing | 3 business days | — | $549 |
| MoCRA package | Cosmetic brands | Facility registration, 5 product listings, one label check | 5 business days | $1,378 | $999 |
| Additional cosmetic product listing | Brands with more products than the package covers | Listing number for that product | Filed with the same submission | — | $120 |
| Label compliance review | Supplements, food, cosmetics | Written review and correction list | 3 business days | — | $349/SKU |
| Amazon / ecommerce claim review | Marketplace sellers | Claim risk map and rewrite suggestions | 3 business days | — | $249/listing |
| D-U-N-S number filing | Foreign plants without a DUNS number | A DUNS number, which FDA registration requires | Tracked until issued | — | $149 |
| EIN filing | Clients importing in their own name or forming a US entity | EIN issued by the IRS | Same call by phone, about 4 business days by fax, about 4 weeks by mail | — | $199 |
| US company formation (you choose the state) | Foreign clients setting up a US entity | Filing in the state you choose, plus the EIN | Per state processing | — | $599 |
| Company formation + US Agent bundle | Clients who need both a US entity and a US Agent | Formation, EIN, and a full year of US Agent | Per state processing | $898 | $699 |
| CBP importer number (Form 5106) | Foreign companies acting as importer without a US entity | CBP-assigned importer number | Per CBP processing | — | $299 |
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