Where to find a Qualified FDA Supplier Auditor located in China

[NicoleinFlorida]

Hello Cove,

Our company is looking for a FDA supplier auditor who can help us with supplier corrective actions of our supplier in China. Because of special issues, the previous auditor cannot perform the re-audit, and we prefer someone located in China.

Do you have any recommendations? Or where can I get the information?

Thank you.

 

[Sidney Vianna]

Re: FDA internal auditor located in China

It's unclear what you mean by an FDA internal auditor. Do you mean someone who works for the FDA? If the person works for the FDA, s/he can not work as a freelance for other organizations.

Please clarify what you are looking for.

 

[shimonv]

Re: Where to find a Qualified FDA Internal Auditor located in China

Yes, its a bit unclear. Are you looking for an auditor located in China who can review the adequacy of an corrective action requested by US FDA and implemented by your supplier in China?

-Shimon

 

[NicoleinFlorida]

Re: FDA internal auditor located in China

Hello Sidney,
Thanks for the comments. I have added the clarification in the post.
I am looking for an auditor who can review the adequacy of our supplier in accordance with FDA QSR.

 

[NicoleinFlorida]

Re: Where to find a Qualified FDA Internal Auditor located in China

Hello Shimonv,

I am looking for an internal auditor to re-audit our supplier to close the Supplier Corrective Actions and also evaluate their adequacy of QSR compliance.

 

[Sidney Vianna]

Re: Where to find a Qualified FDA Internal Auditor located in China

Nicole, just to clarify it; you are not looking for an INTERNAL auditor. You are looking for a supplier (2[sup]nd[/sup] party) auditor.

 

[NicoleinFlorida]

Re: Where to find a Qualified FDA Internal Auditor located in China

Thanks for the clarification. That makes more sense.

 

[Access2hc]

Re: Where to find a Qualified FDA Internal Auditor located in China

Can help as there's team member in China, but how?

Cheers,
Ee Bin