7 replies to this topic

[lindsaysheppard91]

I went on the FDA website to register, and it said this ...

 

"In accordance with Section 415 of the Federal Food, Drug, and Cosmetic Act, you are not required to register. As defined in 21 CFR 1.225, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with the FDA. Please be advised that if you choose to proceed with registering, you must comply with all registration requirements and other statutory requirements of the FD&C Act that may apply. "

 

I am a packaging manufacturer, and food is not processed, or stored here. Whenever I see any Audit documents it says we must be registered with the FDA, so I am a little confused why when I tried registering, it says we are not required.  Also, because of the government shut down, I can't speak to anyone at the FDA office.

 

Any help would be greatly appreciated.

[SQFconsultant]

A. You are not required to register.

B. Make a copy of the website statement and keep it on file so that when a well meaning auditor comes in and says.. hey, where's your FDA registration!?!

You simply show the get out of jail letter and be done with it.

Now, as you found out... you can register anyway - but seriously why bother.

Unless of course one of your customers is demanding it.

[Hoosiersmoker]

We're a Food Packaging manufacturer and we have never been (and don't intend to) an FDA registered site. We have a couple of customers that added that requirement in Repsitrash but I called them and explained the rule to them and they eliminated the request.

[sangle]

We too are a food packaging facility, how does that exemption affect the new IA rule?  I have question about food fraud vulnerability assessments too.  I did the assessments on our RM, PFD and FG and they came back as low risk.  Our last audit (FSSC and ISO 9001) the auditor said it was a good start and asked if I was monitoring the food contact materials for fraudulent activity. Is there a site dedicated to paper, steel and poly liners to monitor?

Thanks

Shanna

[cosmeticqg]

Hello All, 

Because your answer was so helpful, I figured I would ask regarding distribution centers. Do warehouses that store and distribute packaged goods without any special environmental controls, e.g., spices and coffee, require registration with the US FDA? Thanks for your response! 

Edited by cosmeticqg, 23 September 2024 - 05:04 PM.

[jfrey123]

Hello All, 

Because your answer was so helpful, I figured I would ask regarding distribution centers. Do warehouses that store and distribute packaged goods without any special environmental controls, e.g., spices and coffee, require registration with the US FDA? Thanks for your response! 

 

 

From the OP:  As defined in 21 CFR 1.225, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with the FDA."

 

Full code here:  eCFR :: 21 CFR Part 1 Subpart H -- Registration of Food Facilities

[cosmeticqg]

Thank you. Does anyone know what type of information an US FDA inspector would be looking for during a routine inspection? For tea and coffee, I'm assuming traceability and  general warehousing controls. Is there anything else I should be concerned with? 

Thank you very much! 

[jfrey123]

FDA inspections are pretty rare.  The registration topic being discussed usually has to do with the Bioterrorism Act of 2002 which was intended to help the FDA know where food makers/holders are once they identified terrorism as a risk to the food chain.

 

FDA in general is going to expect compliance with Code of Federal Regulation entirely.  You're subject to GMPs, record keeping, document control, FSMA compliance, food defense, traceability, pest control, I mean essentially a whole slew of regulations.  If holding food is a new prospect for your company, there's a lot that goes into warehousing food vs non-food items.