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I want to discuss the following situation with all of you, how to do the establishment register?
Company A locates in address X, where it doesn't manufacture. Instead, company A rent one building of Company B to produce the blood glucose strips. moreover, company B manufactures blood glucose meter for company A, then company A sell the whole blood glucose monitor system.
Now the company A need to register in FDA.
I want to know who is the owner/operator, the address of the owner/operator. who is the manufacturer, the address of the manufacturer.
Company B must be the contracted manufactuer of company A, and company A should include this information when register the establishment?
Thank you.
Company A locates in address X, where it doesn't manufacture. Instead, company A rent one building of Company B to produce the blood glucose strips. moreover, company B manufactures blood glucose meter for company A, then company A sell the whole blood glucose monitor system.
Now the company A need to register in FDA.
I want to know who is the owner/operator, the address of the owner/operator. who is the manufacturer, the address of the manufacturer.
Company B must be the contracted manufactuer of company A, and company A should include this information when register the establishment?
Thank you.