By Vincent Cruz
“Hiring” a U.S. agent means designating a person or business in the United States as your facility’s official FDA contact on your MoCRA facility registration. Here is what a full-service appointment looks like, what you need to provide, how long it takes, and what it costs.
What the service includes
- Intake and document review – we collect your facility details, brand names, and product categories, and check for gaps before anything is filed.
- FEI status check or request – we verify whether your facility already has an FDA Establishment Identifier, and request one if it does not.
- Registration preparation – your facility registration is drafted in the FDA’s Cosmetics Direct portal format.
- Human review with you – every field is reviewed with you, and nothing is filed until you approve it in writing.
- Filing and designation – the registration is submitted naming us as your U.S. agent.
- Ongoing representation – we receive and coordinate FDA correspondence for your facility while you are subscribed.
- Biennial renewal – your facility registration renewal filing is included while your subscription is active.
- Clean exit – if you cancel, the paid month runs out and we file a formal resignation. Your registration is never silently abandoned.
What we need from you
- Facility legal name and physical address
- A contact person at the facility (name, email, phone)
- Brand names manufactured or processed at the facility
- Product categories
- Your existing FEI number, if you have one
- Responsible person details for product listings
Timeline
The longest lead item is the FEI: FDA guidance describes FEI requests as typically processed in 7-10 business days, so plan for about two weeks. Once the FEI is in hand and your documents are complete, the registration itself can be prepared and filed within days. See our realistic registration timeline for the full breakdown.
Cost
$450 one-time onboarding per facility, plus $34.99/month for continuous representation. No per-product surcharge. FDA itself charges no fee for facility registration or product listings – you pay only the service fee.
What happens if you cancel
Your paid month runs its course, and we file a formal resignation as your U.S. agent. You will need a replacement agent on record, since a foreign facility must have a designated agent at all times. Your FEI number, registration history, and product listings are unaffected.
Frequently asked questions
Can our U.S. distributor be our agent instead?
Only if they are formally designated on your registration and accept the responsibilities. Most distributors will not. A dedicated agent keeps the roles clean.
Do you file product listings too?
Product listings are the responsible person’s filing. We coordinate them with your registration so the facility and product records line up.
We already have an agent. Can we switch to you?
Yes – see our transfer guide.
How do we start?
Write to usmocra@outlook.com or start at usmocraagent.com. We will send the intake form and walk you through the documents.
US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. This article is for informational purposes only and is not legal advice.
See also: how much a MoCRA U.S. agent costs — a provider-by-provider price comparison.