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Must a packaging manufacturer be registered with the FDA?

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#1 lindsaysheppard91


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Posted 16 January 2019 - 04:05 PM

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.

#2 SQFconsultant



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Posted 16 January 2019 - 04:33 PM

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.

Kind regards,


Glenn Oster
GOC GROUP / +1.800.793.7042 / Food - Food Packaging - Food Storage/DC

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http://www.GlennOsterConsulting.com  -- 











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#3 Hoosiersmoker


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Posted 23 January 2019 - 04:37 PM

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.

#4 sangle


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Posted 10 January 2020 - 09:42 PM

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?



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