FDA Certificates for all Ingredients

Halo,

One of my importer is asking me about FDA Certificates for every ingredients that i used in my product. Actually, i'm not sure about FDA Certificate for ingredients/raw materials. My question, is it still comply if i give her BRC or FSSC Certificate instead of FDA certificate ?

Any help, information and guidance will be greatly appreciated :) 

Best !

Dafino

Hi, Dafino;

Your importer is basing this on Foreign Supplier Verification Program (FSVP), which is a risk based preventative controls methodology per CFR Title 21 Part 117. So, what they ask for is what they have determined to be critical for a foreign supplier approval. You will have to ask the importer if 3rd party audits meet their approval requirements.

Certificates for export are commonly issued by the FDA for foreign governments, essentially stating that this specific commodity meets regulatory controls. If the FDA inspects your facility, I can only assume that this should be issued. However I do not believe (someone correct me if I'm wrong) this is based on a product and not its components. 

If the FDA has an MOU with your countries regulatory body, and you have evidence of compliance then this should be sufficient for approval (IMO).

I have attached some FDA guidance documents:

FSMA-FSVP coverage flowchart - v4-.pdf   68.29KB   26 downloads

FDA Export Guidance for Industry.pdf   25.49KB   20 downloads

Thanks for the info and for the FDA Guidance documents. I will explain more about BRC/FSSC Certification to our importer.

Best !

Dafino