§607 Facility Registration & Product Listing
Facilities that make cosmetics for the U.S. market must register with FDA, and the responsible person must list every marketed product and update the data each year.
Key obligations
- Register each manufacturing and processing facility within 60 days of first sale and renew yearly.
- Track FDA Establishment Identifier (FEI) status for internal and contract sites.
- Submit product listings with label images, responsible person details, and formulation basics.
- Update listings within 60 days when formulas, labels, or distribution change.
Evidence regulators expect to see
- Facility roster with FEI status and contact information.
- Product master list showing categories, professional-use flags, and planned launches.
- Label governance records that prove change control before printing.
- Distribution data connecting lot codes to customers for traceability.
Intake sections that populate this section
Relevant SOP templates
Risk of non-compliance
- FDA can suspend a facility registration, blocking U.S. distribution.
- Imports can be detained if the site lacks a valid FEI number.
- Retailers may decline onboarding without proof of listings.
Further reading
Use these notes to brief leadership and justify remediation work. As you complete the intake, the Generate Package step merges your answers into each SOP so you can demonstrate compliance with §607 Facility Registration & Product Listing.