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USFDA's Foreign Facility Inspection

USFDA regulation foreign facility best practices

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#1 Satya Vavilapalli

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Posted 23 February 2015 - 05:01 PM

let's have a discussion on USFDA's foreign facility inspection

 

can any one help me . . how much time it take to inspect a facility after issuing inspection notice and what are all the common best practices they look into and audit methodology and checklists

 

Because recently we got an inspection notice regarding as we are exporting to US . .our production process is dry, we produce raw product.

 

 

 

Regards

 

Satya


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Regards

 

Satya


#2 Charles.C

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Posted 23 February 2015 - 11:51 PM

let's have a discussion on USFDA's foreign facility inspection

 

can any one help me . . how much time it take to inspect a facility after issuing inspection notice and what are all the common best practices they look into and audit methodology and checklists

 

Because recently we got an inspection notice regarding as we are exporting to US . .our production process is dry, we produce raw product.

 

 

 

Regards

 

Satya

 

Dear Satyanarayana,

 

i thought this normally only occurred if a MOU (memorandum of understanding) for the product category existed between the 2 countries. Which IMEX is rare, eg Canada.

 

But maybe it also depends on your type of business, eg the sensitivity from a US POV..

 

Are you exporting wheat flour ?

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C






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