How to approve overseas suppliers?

Hello, under Sec. 117.410 General Requirements applicable to a supply-chain program (5) (b) (1) Onsite audits.

What if my suppliers are overseas?

Thank you!

Question your certifying body, they should have references to this...

The person who conducts the audit has to be qualified to conduct audits to the FDA regulation standard.  FDA has recently released its plans for a registry for accreditation bodies and will soon be approving third party auditors.  Most of them are expected to be government officials in the foreign countries, but private certification bodies are no doubt going to try to be accredited as well.  Also, if FDA has inspected your foreign supplier, you should ask for a copy of that audit.  

Hello, under Sec. 117.410 General Requirements applicable to a supply-chain program (5) (b) (1) Onsite audits.

What if my suppliers are overseas?

 

Thank you!

Hi kglara,

I think you are indirectly talking about FSVP ?

If so, can try  this post/thread/attachments -

http://www.ifsqn.com...rd/#entry113320

If not, apologies in advance. :smile: