Cosmetics

Form 2511: Registration of Cosmetic Product Establishment

Filing Form FDA 2511 is the way to register your cosmetic establishment with FDA. You also can use this form to amend establishment registration information or to cancel an establishment registration.

Please take a few minutes to read the following information and instructions for using the VCRP online registration system. This material is designed to familiarize you with Form FDA 2511 - Registration of Cosmetic Product Establishment - in order to make your participation in the VCRP as easy as possible. You may want to print out these instructions for easy reference when you are filling out your forms.

Instructions on How to Complete Your Form FDA 2511 - Registration of Cosmetic Product Establishment


Instructions on How to Complete Your Form FDA 2511 - Registration of Cosmetic Product Establishment:

First, you will need to determine whether you are submitting an original establishment registration, amending or canceling an existing establishment registration, or resubmitting an establishment registration that was returned for action.

Type of submission:

  • If this is the first time you have filed a Registration of Cosmetic Product Establishment under this name, under this management, at this location, this is an original submission. If you have more than one location, register each location separately. Read the instructions for filing an original registration.
  • If you have registered this establishment before and are adding, deleting, or amending a parent company or other business trading names, this is an amendment. Read the instructions for filing an amended registration.
  • If the establishment no longer conducts business under the same name or at the same location stated in its current registration, this is a cancelation. Read the instructions for canceling a registration.
    NOTE: Minor name changes, such as changing "CO" to "INC" do not require a cancelation.
  • To register under a new name or at a new location, submit a cancelation for the name that is no longer in use, then file a new original registration. Read the instructions for canceling a registration and filing an original registration.
  • If you are resubmitting an establishment registration that has been returned for action, see Resubmitting a Cosmetic Product Establishment that was returned for action.

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Registering an Original Cosmetic Product Establishment

Before you register an establishment for the first time, you must set up an account. Select "Request new account" and fill in the information as indicated. After you submit your account request, you will receive a temporary password by email. You should then log into your account using this temporary password and create a new password. We recommend that you keep your new password in a safe place.

To register an original cosmetic product establishment, select "Submit" in the top menu bar followed by "Submit Original Cosmetic." For security reasons, your login will "time out" after 15 minutes of inactivity, so it will help to have all necessary information ready when you begin. You will be asked to submit the following information:

Type of Establishment

Indicate whether the type of establishment is a manufacturer, packer, or other, such as a distributor, retailer, business office, or any combination of these types.

Establishment Name

Enter the name under which you are registering the establishment at this physical location under this management. Use customary abbreviations, such as "CO" for "company" and "INC" for "incorporated."

Parent Company Name (if any)

If the company is a subsidiary to a parent company, such as Smith and Company, Division of Jones International, Incorporated, enter "SMITH & CO" for the establishment name and "JONES INTERNATIONAL INC" in the space for Name of Parent Company.

Address

Enter the address of the establishment's physical location. For establishments in the United States, include the street address, city, state, and ZIP Code.

For establishments outside of the United States, you may enter territorial subdivisions (such as province or prefecture) in the space for state. Postal codes for addresses outside the U.S. are optional. If you choose to include a postal code for an address outside the U.S., enter it in the ZIP/Postal Code field.

Note: A Post Office Box number is not an appropriate cosmetic product establishment address.

Address Location

Indicate whether the address on the form is the location of a cosmetic manufacturing, and/or packing facility.

Owner or Operator of the Facility

Indicate whether you are the owner or operator of the facility.

Other Business Trading Names

These are defined as subsidiary or related firm names used on a cosmetic product label, which are owned by the cosmetic manufacturer or packer, but are different from the principal name under which the cosmetic product manufacturer or packer is registering or is registered. If you produce cosmetics under other business trading names, please list those names here. Select "Add Other Business Trading Names" to enter as many other business trading names as you need.

Establishment Authorized Individual

Select an establishment authorized individual name from the drop-down menu. If you are a staff member or consultant participating in VCRP on behalf of a company, then select your name in the alternative authorized individual name field.

Additional alternative authorized individuals can be added to your account by selecting “Add New Alternative Authorized Individual” from the main menu.

Submit Establishment

When you have finished, you may select "Close" if you do not wish to save this data, or you may select “Save Draft” if you wish to save your progress and continue with your registration at a later time. If the information is correct and you wish to submit this registration, select "Submit and Return to Previous Page." You will receive an email indicating that you have successfully submitted Form FDA 2511 for our review.

When you have completed your Form FDA 2511, you may then return to the “Submit” page to submit an additional Form FDA 2511, or move on to Form FDA 2512.

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Amending a Cosmetic Product Establishment

Log into your account and view the "Cosmetic Establishment (Form FDA 2511)" section on the main menu. Next, select the “Establishment Name” of the establishment you want to amend.

You will see the information currently on file for that establishment. Select “Amend Form” from the upper right-hand corner. Carefully review the information and replace the obsolete information with the current information wherever necessary. Check your new information for accuracy, then select "Resubmit and Return to Previous Page."

Canceling a Cosmetic Product Establishment

Log into your account and view the "Cosmetic Establishment (Form FDA 2511)" section on the main menu. Next, select the "Establishment Name" of the establishment you want to cancel.

You will see the information currently on file for that establishment. Make sure that you have selected the correct establishment to be cancelled. To cancel the establishment registration, select "Cancel This Form" from the upper left-hand corner.

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Resubmitting a Cosmetic Product Establishment that was Returned for Action

If your cosmetic product establishment was returned for action, that means FDA has a follow-up question about the information in the Form FDA 2511 that you have submitted. To view the follow-up question and resubmit your cosmetic establishment, read the instructions for Reviewing a Cosmetic Product Establishment, then view the message in the comment section at the bottom of your Form FDA 2511.

To respond to the comment, or make changes to the information you have submitted, select "Resubmit Form" from the upper right-hand corner. Check your information for accuracy, then select "Resubmit and Return to Previous Page."

Reviewing a Cosmetic Product Establishment

Log into your account and view the "Cosmetic Establishment (Form FDA 2511)" section on your main menu. You will see a list of your establishments currently registered, or submitted for registration, in the VCRP.

Next, select the "Establishment Name" of the establishment you want to review. You will see the information currently on file for that establishment. You may review the information on this page, make amendments, or cancel the establishment if necessary.

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Transferring Establishments That You Have Filed Previously on Paper Forms to Your New Online VCRP Account

Send an email to VCRP@fda.gov with your establishment registration number(s) and the name of the new online VCRP account, so that FDA can process your request.

Deleting a Cosmetic Product Establishment

You can delete establishments that have never been assigned an establishment registration number. To do this, open the establishment you want to delete and select "Delete this Form."

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Page Last Updated: 09/20/2018
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