SQF 2.3: FDA registration for a laboratory

Hi all SQF experts, so i was reviewing 2.3 contract service providers policy (which i did not write, it was the previous administration) and as a requirement asks for accreditation from ISO 17025 (which I'm aware that its a requirement from the code) and also to be registered with the FDA now this I have not idea where it came from (as i said i didn't write this policy) so my question is do any of you guys have and auditor asking you for FDA registration from your lab? Does FDA requires laboratories to be registered with them? please help me get some enlightenment on this.

Thanks.

Brenda  

Hi all SQF experts, so i was reviewing 2.3 contract service providers policy (which i did not write, it was the previous administration) and as a requirement asks for accreditation from ISO 17025 (which I'm aware that its a requirement from the code) and also to be registered with the FDA now this I have not idea where it came from (as i said i didn't write this policy) so my question is do any of you guys have and auditor asking you for FDA registration from your lab? Does FDA requires laboratories to be registered with them? please help me get some enlightenment on this.

 

Thanks.

 

Brenda  

I'm not in USA but I doubt  that FDA are in the business of registering labs.

Hi Brenda,

The FDA does not accredit laboratories.  There is a requirement in the FSMA rule for accreditation but it refers to the FDA's own internal labs and any that they contract with to perform regulatory testing.  This article explains it pretty good.

https://www.foodprot...a-article-7.pdf

We just require that any 3rd party lab we use meets the requirements of ISO 17025.  That has been acceptable for every SQF audit we have had including Edition 8.0.  We have also had an FDA Preventive Controls audit and it was acceptable for that as well.

Hope this helps.

Thank you so much all.

Brenda