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Facility registration is conducted through the FDA’s Cosmetic Direct Portal. To complete your registration, you’ll need to submit the following information:
- Owner/Manager Details: Name of the facility’s owner or manager.
- Facility Information: Name, address, email, and phone number of the facility.
- U.S. Agent Contact (for overseas facilities): Name, phone number, and email (if available) of the U.S. agent.
- FEI Number: Facility Establishment Identifier number.
- Brand Names: All brand names under which cosmetic products manufactured or processed in the facility are sold.
- Product Categories: Product category or categories and the responsible person for each cosmetic product manufactured or processed at the facility.
- Submission Type: Whether the registration is an initial submission, renewal, or amendment.
Additional Information Requested by the FDA:
- Parent Company Name: If applicable.
- DUNS Number: Data Universal Numbering System number.
- Additional Contact Information: For individuals associated with the registration.