FDA compliance 2

[LJthien]

Hi all,
I am purchasing some gasket and sealing materials from a manufacturer based in Europe, which should be FDA compliance.
My understanding is that if the sealing material is the type approved and listed by FDA then we can accept it without any addition FDA compliance certificate.
Please advise if my understanding is correct or I need some supportive compliance certification.
Thanks for your support.

 

[pierreick]

Hi,
It does not hurt to get the certificate from the manufacturer. If there is a request from inspector during the audit the proof will be welcome. Material could be approved by FDA but you need the proper certificate.
Cheers,
Pierre

 

[EdStainless]

For some materials there are published lists.
Making sure that you order parts correctly and ask for the correct documentation is the key to getting this right.

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P.E. Metallurgy, consulting work welcomed

 

[LJthien]

Thank you Pierreick and EdStainless,
I have inquired the supplier and what I will receive is a Certificate of Quality (2.1 type certificate) from the manufacturer for self declaration of FDA conformity, and the sealing material itself is PTFE type which is approved by FDA in 21CFR177.1550.
But I 'm not sure if those are adequate since this is the first time I use FDA approval material for my project.
Warm regards.

 

[3DDave]

You need to contact the FDA sometime, so might as well start now.

 

[LJthien]

@3DDave
What do you mean contact the FDA? I thought FDA just approve safe materials only, not brand name of any products.
Thanks.

 

[3DDave]

If what you are making is under the authority of the FDA you will need to show that your product and process conforms.

Maybe elaborate on what you are actually going to produce and why you think FDA approved materials is required.

 

[pierreick]

Hi,
As I said Material could be approved by FDA but what is important is that the supplier for this material is qualified by FDA. It should provide the necessary certificate showing that its production is compliant with FDA.
Pierre

 

[LJthien]

@ Pierreick,
"what is important is that the supplier for this material is qualified by FDA".

That is what I am not experienced and want to learn. Can you elaborate how a supplier is qualified by the FDA? Does it mean supplier is registered in the FDA 's web.
Thanks.

 

[pierreick]

Hi,
Yes, the supplier should be registered to supply on the regulated market and get inspection from FDA.
My experience in the pharmaceutical business.
Here we are talking about the material in contact with the product, for examples: metal screens on a sifter or filter cartridge.
Pierre

 

[quark]

You need to have food grade certificate as a minimum requirement. If you are in to liquids, the current practice is to get leachable and extractible certificates, as well.

 

[MortenA]

Get the ceriticate! A vendor will say (almost) anything to get a sale...

--- Best regards, Morten Andersen