Why FDA Facility Registration is Required
for Cosmetics Manufacturing?
Legal background
Without a valid FDA facility registration and FEI number, your cosmetic products cannot be legally marketed in the United States. Proper facility registration safeguards your market access, regulatory standing, and business relationships.
Non-compliance with MoCRA’s requirements can lead to:</span
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- Product detention at the port of entry
- Mandatory product recalls
- Facility registration suspension and prohibited from supplying products to the U.S.
- Loss of business opportunities
Our services
How Obelis Ensures your Facility Registration and FEI Compliance
At Obelis, we make the FDA facility registration process and FEI number assignment seamless and stress-free. Our experts:
We handle your complete FDA facility registration process from start to finish. Our services include obtaining your Facility Establishment Identifier (FEI) Number, preparing and submitting your registration through the FDA’s Cosmetics Direct portal, and managing all required biennial renewals to keep your registration current. For foreign facilities, we act as your U.S. Agent, ensuring direct and effective communication with the FDA. We also update your registration whenever facility details change, minimizing compliance risks and ensuring continuous access to the U.S. cosmetics market.
FAQ
Frequently Asked Questions
Any company, domestic or foreign, that manufactures or processes cosmetics for the U.S. market must complete FDA cosmetic facility registration. Foreign facilities must also appoint a U.S. Agent to serve as their official point of contact with the FDA.
FDA cosmetic facility registration must be renewed every two years (biennially) and updated promptly if there are changes to your facility information. Failing to renew or update your registration can result in suspension and loss of market access.
Non-compliance with FDA cosmetic facility registration requirements can lead to product detentions at U.S. ports, mandatory recalls, suspension of facility operations, and the inability to legally market cosmetics in the United States.
No. FDA cosmetic facility registration confirms your facility’s compliance with MoCRA’s manufacturing registration requirements, but it does not constitute product approval. You must still ensure each cosmetic product meets all safety, labelling, and ingredient regulations before it can be sold in the U.S.
To apply for FDA cosmetic facility registration, you must first obtain an FDA Establishment Identifier (FEI) number, then submit your facility details through the FDA’s Cosmetics Direct portal. The process involves providing accurate manufacturing information and updating it as required. Working with Obelis ensures your application is complete, compliant, and processed without delays.
