Are there any regulations on where a product is manufactured?

[J0shu9]

hey guys,

I am wondering if I am manufacturing a registered product with the fda, does it have to be in a ISO certified lab? Is it legal for a buisness that is registered with the fda to manufacturer a fda registered and compliant product/products from home? Are there any regulations on the facility it self? I have a old eliquid brand that I want to bring back to market that is registered and compliant along with my buisness being registered with the fda as a Manufacturer but I no longer have my facility that I used to so I would have to do it from my make shift lab I have in my home now.

Thanks for any input!

 

[bombastinator]

These questions are best directed towards the relevant regulatory group. One would assume considering your repeated references that you at least believe it is the FDA. What did they say?

 

[Eskie]

That you would need to check with the FDA about. No one here is capable of evaluating your facility sight unseen to say it will meet FDA compliance standards. If you choose to build an ISO complaint room in your house that meets their standards and follow GMP, I expect you could be approved. It's not the house that matters, it's the facility, whether in your house or in a warehouse space that needs to meet all the standards.

You will have to register that old formula if you want to manufacture it, and you will have to submit a PMTA within about 10 months for it to remain on the market unless you get an individual waiver.

 

[vapdivrr]

Bring back the pluid

 

[vsummer1]

I happen to know that a well recognized brand of eliquid is indeed made at the home of the business owner. They have an area designated solely to production. I can't imagine they advertise the fact though

As to whether or not they got any type of approval at all? I doubt it. It's all online sales and I don't think there's anyone going around checking on it.

 

[BrotherBob]

hey guys,
I am wondering if I am manufacturing a registered product with the fda, does it have to be in a ISO certified lab? Is it legal for a buisness that is registered with the fda to manufacturer a fda registered and compliant product/products from home? Are there any regulations on the facility it self? I have a old eliquid brand that I want to bring back to market that is registered and compliant along with my buisness being registered with the fda as a Manufacturer but I no longer have my facility that I used to so I would have to do it from my make shift lab I have in my home now.
Thanks for any input!

"Are there any regulations on where a product is manufactured?"
Might want to adhere to:
re: Facts About the Current Good Manufacturing Practices (CGMPs)
"does it have to be in a ISO certified lab? "
If I remember correctly back in the 90's, ISO was strictly voluntary and nice to have Reg. Today, Medical Devices seem to be of interest to the FDA. Could read through:
E Liquid manufacturing - U.S. Food and Drug Administration Search Results