Who should submit an original establishment registration (Form FDA 2511), and when?
Any firm that manufactures or packages cosmetics may submit an establishment registration. This includes contract manufacturers or packers of a cosmetic, as well as foreign cosmetic product establishments whose products are exported for sale in the United States (21 CFR 710.1). A firm should submit an establishment registration within 30 days of beginning operations (21 CFR 710.2).
Related Questions
- If I wish to participate in the VCRP, do I need to file both a Form FDA 2511 (Establishment Registration) and a Form FDA 2512 (Cosmetic Product Ingredient Statement)?
- Who should submit amendments to an establishment registration (Form FDA 2511), and when?
- Who should submit an original establishment registration (Form FDA 2511), and when?
