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Good morning,
Our distributor informed us that ANVISA planned an inspection for our company.
1) We are French "manufacturer" according European directive but we subcontract the manufacturing to a Chinese factory.
I could understand that this inspection is a Br-GMP inspection of the manufacturing site/factory. In our context, which company ANVISA will more probably inspect : our company in France (we are only offices: The activities are design and development, marketing, sales and after-sales service) or the Chinese factory ( which manufactures and tests the devices)?
It could cause some problems because we doesn't want to divulgate the name of the chinese factory to our Brazilian distributor.
2) One of our Brazilian contact told us that there is a list of companies planned to be inspected on ANVISA website. But I check the website and I'm not be able to find it.
Does somebody knows how to find this information on ANVISA website or have the web link?
Thank you for the answers,
BR
Our distributor informed us that ANVISA planned an inspection for our company.
1) We are French "manufacturer" according European directive but we subcontract the manufacturing to a Chinese factory.
I could understand that this inspection is a Br-GMP inspection of the manufacturing site/factory. In our context, which company ANVISA will more probably inspect : our company in France (we are only offices: The activities are design and development, marketing, sales and after-sales service) or the Chinese factory ( which manufactures and tests the devices)?
It could cause some problems because we doesn't want to divulgate the name of the chinese factory to our Brazilian distributor.
2) One of our Brazilian contact told us that there is a list of companies planned to be inspected on ANVISA website. But I check the website and I'm not be able to find it.
Does somebody knows how to find this information on ANVISA website or have the web link?
Thank you for the answers,
BR