Language of quality system in case of FDA inspection

LAM2020

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#1
Hello,
we are a french manufacturer and we are going to apply for a 510k. In case we have an inspection from the FDA do we have to have all our documets from our quality system in English? Or just some ? Thank you
Kind regards
 
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#2
Hello,
we are a french manufacturer and we are going to apply for a 510k. In case we have an inspection from the FDA do we have to have all our documents from our quality system in English? Or just some ? Thank you
Kind regards
Having worked in China, I can definitely tell you to have the Quality Manual and Procedures bilingual while it is desirable to have the work instructions bilingual.
.
 
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