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FDA requirement on manufacturing facility registration


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Sankani

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Posted 26 June 2022 - 11:41 PM

Hi Team, 

Can anyone please advise that if it is necessary to have a GFSI approved quality system to go for an FDA manufacturing facility registration? 

Our facility is basic HACCP certified and I can understand that FDA has more thorough requirements on VACCP, TACCP and supplier approval. 

Any thoughts on this is highly appreciated. 

 

Thank you very much. 



SQFconsultant

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Posted 27 June 2022 - 01:58 AM

There is no requirwment foe the GFSI.


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Glenn Oster

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SQFconsultant

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Posted 27 June 2022 - 01:59 AM

Sorry for the typo's


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Glenn Oster

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Sankani

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Posted 27 June 2022 - 11:49 PM

Thanks for the quick respond Glen. Much appreciated. 



Sankani

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Posted 28 June 2022 - 06:15 AM

Hi Glenn, just another quick question.

 

We are manufacturing infant formula in Aus and to export to USA we need to get both the product approval and facility registration. I've recently heard that under the emergency presidential resolution the facility registration part is not applicable as far as we can provide the HACCP, supplier verifications, environmental monitoring, zoning, third party audit details etc. 

 

Do you know much about this?

 

Thanks 



Kara S.

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Posted 28 June 2022 - 12:46 PM

See link below for current guidance. 

 

https://www.fda.gov/...158476/download


Kind regards, 

 

Kara Scherer 

Food & Beverage Industry Consultant

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