A Look at the FDA Registration Renewal

Well, FDA requires that new food facilities have to register, and for the ones which are already in operation, their owners have to renew the facilities once every 2 years (on the even year), starting from now on (2012). 

I got some third party agents' letters that offered the renewal service months before that. Perhaps I did not know this requirement earlier if I did not get these offers, so in fact I have to thank them for this! For FDA they are thoughful enough to clearly state that all the third parties who offer the service are quite independent from FDA. The most active agent is perhaps Registrar Corp. This name seems OK to me, however once I received similar letter from an agent with the name as FDA Registrar. One of our buyer received similar letter had urged us to contact FDA Registrar to do the registration or problem would happen to our business! It looks like the letter was from FDA itself, and made them think that there was changes in FDA registration policy, so they urged us to contact them!

FDA has a guide for the biannual renew at its link at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/OnlineRegistration/ucm324780.htm. Actually afternoon of Oct. 22 VN time (this means some hours after FDA registration web site became active), I had logged in and check myself the works one have to complete to renew the facility. It is rather simple work, and here is what I found (I just examined how to do it; but our factories have not been renewed so far).

Before you actually renew your registration, carefully collect all the necessary information you would use for filling in the form. The best one is the one you used when you first registered it (the data is available in the form itself), and what has changed since then, so you have chance to correct/renew it.

Then you can login your account. This is simply enough, for any one who has an account and password to login FDA site, he can do it.  Suppose that you had one, then just type your user name and password to log in its site (http://www.fda.gov/furls). Then sellect the topmost case (Form 3537/3537a) at the first page appears right after you login sucessfully.

This FDA account requires a very secured password, after certain time, it asks you to change password when you login, and the password must be a combination of upper case, lower case letters and symbol; it must be not too short and not too long! It is difficult for you to remember such password after some time, so the best way is to write it down and keep it where you can find it when need it.

After login, the first page appears with lot of options (8 in total!), and the first option is for biennual registration renewal, as you you can see in the below picture.

Main menu

Figure 1: The Main Menu

After you click on the first option, you will see the renewal page where you can edit your earlier input information. If most of the data is still correct (this is usually the case), just look for the additional required information in Figure 2 and 3 below. Here you can see most of the new requirements, in Section 5, 6, 7 (Facility Emergency Contact Information, Trade names, United States Agent), Section 11 (Owner, Operator, or Agent-in-charge information); Section 12 and 13 (Inspection Statement and Certification Statement) (see Figure 2,3 and 4.)

Figure 1Figure 2Figure 3

After filling in the required information, or just toggling on the check box, then you can click the Summit Biennial Registration Renewal to complete your registration.

 

 

 

 

English