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Registration in FDA, company only or company and product?


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#1 Magdalena.W

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Posted 27 January 2020 - 02:53 PM

I work in dietary supplement manufacturer in Europe, and we are looking into selling our product in the USA. We would like to register our company with the FDA but FDA controls our product on the market only as a finished dietary supplement.
After we register our company with FDA, will we have the FDA audit our factory? Do we have to register our product (not only the company) as well?



#2 Fishlady

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Posted 31 January 2020 - 08:22 PM

I am not overly familiar with dietary supplement regulations, but for food you are only registering the facility and not the products. By doing this you give FDA permission to audit you, although there is no guarantee when or if they will. But as a foreign company FDA will provide notice before they would audit you; US based companies can be audited by FDA at any time without notice.



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#3 pHruit

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Posted 31 January 2020 - 08:45 PM

It's a while since I did our registration, but IIRC you do give the FDA the right to just turn up and audit unannounced. 
Did make me wonder, as if someone turned up at the factory claiming to work for a foreign regulator then my initial reaction would be that our security protocol says we shouldn't grant access until their identity can actually be verified, and I've no idea what an FDA ID badge/card is supposed to look like... 

We haven't been audited (food) but a number of contacts around Europe have had them turn up.



#4 QAGB

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Posted 31 January 2020 - 09:02 PM

It's a while since I did our registration, but IIRC you do give the FDA the right to just turn up and audit unannounced. 
Did make me wonder, as if someone turned up at the factory claiming to work for a foreign regulator then my initial reaction would be that our security protocol says we shouldn't grant access until their identity can actually be verified, and I've no idea what an FDA ID badge/card is supposed to look like... 

We haven't been audited (food) but a number of contacts around Europe have had them turn up.

 

 

They usually show up with their badges and business cards. In the US, you'll know it's the FDA because they have an uncanny way of showing up right around lunch time (especially on the first day - if they do a multi-day inspection).  :rolleyes:



#5 QAGB

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Posted 31 January 2020 - 09:04 PM

I am not overly familiar with dietary supplement regulations, but for food you are only registering the facility and not the products. By doing this you give FDA permission to audit you, although there is no guarantee when or if they will. But as a foreign company FDA will provide notice before they would audit you; US based companies can be audited by FDA at any time without notice.

 

This is correct (at least for the US). Our facility was registered, and they showed up unannounced. I can't speak to anything outside of the US.



#6 TimG

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Posted 31 January 2020 - 09:05 PM

 

We haven't been audited (food) but a number of contacts around Europe have had them turn up.

 

Do you know if they were contracted to audit on behalf of the FDA or if they were actually FDA employees?

I have always worked in pretty low risk facilities, but I would find it humorous if FDA is out there auditing foreign suppliers on a regular basis.

To put it in perspective, I've worked for 3 separate companies over the last 7 or 8 years and I've had 2 FDA inspections (at different facilities but for the same sugar manufacturer I worked for). The facility I am currently at hasn't had an FDA inspection since 11.23.16!

To answer the OP's post, any time you register as an FDA regulated product you do give them permission to audit your facility as well as the ability to revoke your FDA registration at any time (and publish that they've revoked it!!) among a few other things. I would suggest you run it by your legal department, or your legal representatives prior to agreeing to it. However, if you want to sell in the USA you probably won't have the option on not registering.



#7 pHruit

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Posted 01 February 2020 - 01:41 PM

They usually show up with their badges and business cards.

I'd assumed that would be the case, but alas their badges and cards mean nothing to me here. Maybe I just leave them outside for a few hours until the time difference catches up and I can call the FDA to verify? Should make for a smooth audit  :ejut:

 

 

Do you know if they were contracted to audit on behalf of the FDA or if they were actually FDA employees?

Honestly not sure - largely just "we had the FDA show up out of the blue last week, and it was quite a strange audit" type comments.






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