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MoCRA §607 compliance

Avoid MoCRA detention.
Secure your US agent in 12 minutes.

MoCRA §607 demands a physical U.S. presence for all foreign cosmetic manufacturers. We guarantee instant FDA Cosmetics Direct acceptance and full liability protection for a flat $399/year. Stop paying $1,500+ to legacy consultants.

Appoint Assurentry ($399/yr)

No hidden fees • Cancel anytime • 100% FDA acceptance

MANDATORY RECALL: BACTERIAL CONTAMINATION - EYE DROPS
WARNING LETTER: FAILURE TO REGISTER FACILITY
ADULTERATED: LACK OF SAFETY SUBSTANTIATION
MISBRANDED: FALSE CLAIMS ON LABEL
SERIOUS ADVERSE EVENT: FAILURE TO REPORT WITHIN 15 DAYS
IMPORT REFUSAL: NO RP CONTACT INFO
MANDATORY RECALL: BACTERIAL CONTAMINATION - EYE DROPS
WARNING LETTER: FAILURE TO REGISTER FACILITY
ADULTERATED: LACK OF SAFETY SUBSTANTIATION
MISBRANDED: FALSE CLAIMS ON LABEL
SERIOUS ADVERSE EVENT: FAILURE TO REPORT WITHIN 15 DAYS
IMPORT REFUSAL: NO RP CONTACT INFO
MANDATORY RECALL: BACTERIAL CONTAMINATION - EYE DROPS
WARNING LETTER: FAILURE TO REGISTER FACILITY
ADULTERATED: LACK OF SAFETY SUBSTANTIATION
MISBRANDED: FALSE CLAIMS ON LABEL
SERIOUS ADVERSE EVENT: FAILURE TO REPORT WITHIN 15 DAYS
IMPORT REFUSAL: NO RP CONTACT INFO
Retail enforcement

Blocked by retailers?

Major beauty retailers now require proof of MoCRA registration as a condition of purchase. Without an FDA Establishment Identifier (FEI), you will be delisted.

Vendor Compliance Portal
Missing FDA Registration
SKU Activation Blocked
ACTION REQ
Get FDA registered
Retail Gate
Pass Valid
MoCRA Reg # Verified
Sephora
Ulta Beauty
Amazon
The gatekeeper threat

Import Alert 66-40 is triggered instantly.

If your MoCRA facility registration lapses, or if your U.S. Agent fails to respond to an FDA serious adverse event inquiry, your facility is placed on FDA Import Alert 66-40. Every cosmetic shipment you send to the U.S. will be halted at the port. Demurrage fees start immediately, ruining retailer contracts.

Protect your shipments

Instant CBP unblocking • Immediate digital certificate

Newsletter10:42 AM
FDA | ORA
URGENT
Notice of Action: Facility Inspection
Response required within 24 hours to avoid suspension...
MISSED
LinkedInYesterday
System Alert
Registration Suspended
Cause: Failure to respond (21 CFR 1.227)
FDA Cosmetics Direct

Flawless API integration.

Forget emailing PDFs to legacy consultants. We plug directly into the FDA's new Cosmetics Direct electronic submission portal. Your MoCRA facility registration and U.S. Agent designation are filed instantly with zero human error.

Cosmetics Direct Portal
FDA CONNECTED
Product Name
Luminous Youth Serum
Category: 05A (Skin Care)
Ingredients
RetinolHyaluronic AcidFragrance #4
RP Contact Info
Valid
Facility FEIN
Verified
Safety Substantiation
Uploaded
Labeling Check
Compliant
Submit Listing
New SPL ID
Assigned
Cosmetics Direct
Sync Complete
Radical transparency

The hidden fee trap.

Legacy regulatory firms lure you in with a $449 base fee, then charge $249 for Ingredient Reviews, $199 per Product Listing, and $399 for DUNS assistance. You end up paying $1,500+. We believe in one flat rate: $399/year.

Comparison
Registrar Corp
Legacy Provider
Best Value
Assurentry
Modern Platform
Annual Fee
No hidden costs
$695+
$199
Liability Coverage
FSMA Re-inspection fees
Ambiguous
100% Accepted
Certificate Access
24/7 Portal
Manual Request
Instant Download
Registration Update
Unlimited changes
Add-on Fee
Included
Detention Response
Predictable pricing
Hourly Legal Rate
Flat Fee

Stop overpaying for compliance.

Switching is free and takes less than 5 minutes. We handle the FDA notification for you.

§607

U.S. Agent Mandate

Physical U.S. Address

Must reside in or maintain a place of business in the US.

No P.O. Boxes Allowed

Virtual mailboxes and answering services are explicitly rejected by the FDA.

24/7 Availability

Must be available to receive emergency communications.

Physical presence mandate

The physical presence mandate.

MoCRA §607 dictates you cannot use a virtual office, a P.O. Box, or an answering machine. The law is absolute. We provide a guaranteed legal foothold in the United States.

Secure your legal US address

100% compliant with MoCRA §607

Financial protection

The FDA re-inspection liability trap.

Under FDA regulations, the U.S. Agent is financially liable for FDA re-inspection costs if the foreign facility refuses to pay (often exceeding $10,000). Competitors refuse to act as agents or charge massive retainers. Assurentry absorbs this risk.

Coverage
Re-Inspection Fees
Legal
Liability Accepted
Get the Assurentry liability shield

Included free with your $399 flat fee

Data integrity

Mastering the FEI disconnect.

The exact spelling and address format in the FDA database must cryptographically match the Dun & Bradstreet database to generate your FDA Establishment Identifier (FEI). If it doesn't, your MoCRA registration fails.

D&B
DUNS Database
MATCHED
FDA FURLS
Global coverage

FDA emergencies wait for no one.

The FDA operates on EST. If a serious adverse event or recall notice is sent at 4:00 PM EST, it might be 4:00 AM in your country. We provide 24/7/365 coverage for over 160+ countries.

24/7 Operations Center

New York, USA
09:42 AM
London, UK
02:42 PM
Beijing, CN
09:42 PM
Agents Active Now
Compliance repository

The secure audit vault.

Every MoCRA interaction, facility registration, and product listing is cryptographically stored and instantly accessible for your buyers, retailers, or inspectors.

Compliance Vault
Encrypted • 256-bit
Active2026
Frequently asked questions

Radical transparency.

We answer the hard questions our competitors won't.

One flat fee. Complete peace of mind.

Stop paying hourly retainers for mandatory MoCRA compliance.

Complete package

U.S. agent designation

The complete compliance representation package for cosmetics.

$399/ year
Secure your agent

Secure SSL checkout. No setup fees. Cancel anytime.

What's included:

  • Official MoCRA §607 Designation
  • Liability Shield (Re-inspection fees)
  • Free FDA Cosmetics Direct Sync
  • MoCRA Adverse Event Handling
  • Free DUNS Validation Support
  • Unlimited FDA Comm Handling
  • Digital Compliance Certificate
FDA Status
ACTIVE
Registration Valid
Agent Link
Confirmed
100% FDA Acceptance Guarantee

Secure Your Supply Chain.

Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.

256-bit Encrypted
Instant PDF
4.9/5 Rating
Official US Agent