FDA Industry Systems

Login to FDA Industry Systems (FIS)
Step-by-Step Instructions

Login to FDA Industry Systems

When you choose the LOGIN button from FDA Industry Systems you will arrive at the Login page (Figure 1) from which you can login. On this page (Figure 1) you may also:

Create an Account
Get Help with Your Password
Get Help with FDA Industry Systems

Figure 1:

Login

To login do the following:

1. Type in your account ID and password. (For help creating an account see the Create New Account Quick Start Guide)
2. Review the 18 U.S.C. 1001 statement and select I understand.
3. Select Login.

Fields Included in this Section

Account ID	A system-generated identification code that enables you to log into FDA Industry Systems. Also referred to as an User ID.
Password	A password created by the account holder that allows you to log into FDA Industry Systems.
Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.	Terms that the account holder confirms understanding of in filling out this form.

After successfully logging in, you will see the FDA Industry Systems home page welcome screen (Figure 2).

Figure 2:

If your account was created for you by another person in your company or someone else with authority to register your facility, you will receive an account ID and password via e-mail or postal mail. The first time you log in, you will be required to immediately select a secret question and answer and change your password. You will not be allowed to perform any activities in the system until you have selected a secret question and answer and your password has been changed.

Problems Logging In

If you are unable to login to FDA Industry Systems, one of the following problems may be the cause:

• Too many login attempts

  If you've tried to login with the same Account ID and Password multiple times, your account may be temporarily suspended for security purposes. Wait an hour and try logging in again.

• Forgot your password

  If you have forgotten your password, you can have a new account password sent to you.

  1. Select "Forgot your password?"
  2. Type in your account ID, select your secret question, and type in your secret answer.
  3. Select Continue to complete the process.

  If an e-mail address was provided when your account was created, your new password will be mailed to the e-mail address recorded for your account. If no e-mail address was provided, your new password will be sent to you by U.S. Postal Mail.

• Failure to confirm understanding of the 18 U.S.C. 1001 Statement.

  Under United States Code Title 18, Section 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties. Confirmation that the account holder understands this is required.