Creating a Cosmetic Facility Registration File

Cosmetic Manufacturers and processors must register their facilities with the FDA and renew their registration every two years.:

https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products 

Cosmetic Facility Registration files are created and maintained under the individual Establishment facility in the Establishments Tab of the Contacts/Entities. Before a Cosmetic Facility Registration file can be created the associated Cosmetic Product(s) data must be saved in SPL Portal under the Products page so that those cosmetic products can be added as references in the Cosmetic Facility Registration files. See:

Creating a Cosmetic Product Listing File

To create a Cosmetic Facility Registration file click to load an Establishment's name from the data table, or click the "Create New Establishment" link.

With the Facility/Establishment Registration file data populated and saved in the data fields, select and save the "This establishment is a Cosmetics Facility" checkbox option. Saving the Cosmetics Facility designation to the page will populate an optional "This Cosmetics Facility is a Small Business" checkbox, an "Add/Edit Cosmetic Facility Products" link, and a "Cosmetic Facility Registration Files" link:

Saving the Cosmetics Facility designation to the Establishment will also populate a "Cosmetic Facility" icon on the Establishments Tab's data table for that Facility record. 

Click to load the "Add/Edit Cosmetic Facility Products" link. A new window will open displaying a list of cosmetic product(s) and a "Save Products To Facility" button. Select and save a product(s) record to the facility and then close the window to return to the Establishment's Establishment Detail page.

Once the product record(s) have been saved to the facility, click the "Cosmetic Facility Registration Files" link. This will open a new window that is used to create and download Cosmetic Facility Registration Files. Existing Cosmetic Facility Registration Files are listed in descending order based on version number. To create the Facility Registration file populate the "Registration Type:" dropdown menu and the "Effective Date:" field(the "Version No:" field is automatically incremented by the application.). With those fields populated a Review file can be created by clicking the "Create SPL Review File" button, this will automatically download a review file, this file will not be saved to SPL Portal so please save the review file to your chosen location in order to access it in the future.

Click the “Create Registration” button to create a new Cosmetic Facility Registration File. Once the file has been generated, click the download icon to download the completed file; click the Submit icon to submit the file to the FDA.