The FDA has released its Draft Guidance To Industry on the requirements for FDA Facility and Product Registration.
Go here to read the requirements for Product Registration: https://lnkd.in/gr_vfvi9
Here’s the information that is MANDATORY to be submitted in your FDA Facility registration:
In order to register your facility if you are a Contract Manufacturer or a brand manufacturing your products in-house, you must first get an FDA Establishment Identifier (FEI) number. You can get an FEI through the FDA FEI portal. You will use the FEI when you register your facility, providing:
(1) The name of the owner and/or operator of the facility;
(2) The facility’s name, physical address, email address, and telephone number;
(3) The facility registration number, if any, previously assigned (FEI);
(4) Type of submission (initial, amended, biennial renewal, or abbreviated renewal)
(5) All brand names under which cosmetic products manufactured or processed in the facility are sold;
(6) The product category or categories and responsible person for each cosmetic product manufactured or processed at the facility. The FDA has established 17 product categories each with subcategories. For example: Category (14) Skin care preparations (creams, lotions, powder, and sprays) (f) Moisturizing
(7) With respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email);
As mentioned above, obtaining the assigned facility registration number (FEI) is the first step before starting the registration submission.
FDA also requests that the following additional OPTIONAL information be submitted:
• Parent company name (if applicable);
• Facility DUNS Number (Dun & Bradstreet); and
• Additional contact information for individuals associated with the registration.