FDA Audit - How much advance notice do foreign manufacturers get?

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S

SteveK

#2
Re: FDA Audit

When I worked in the pharmaceutical industry in the UK (involved a few Class I medical devices also), I seem to remember the Regulatory and Quality Departments on site running around like headless chickens for a couple of weeks before the audit. So they must have had this time to prepare as a minimum.:2cents:

Steve
 
M

MIREGMGR

#4
Advance notice implies the equivalent of a QSIT-1 general-review inspection.

In the US, for-cause inspections to investigate a specific complaint or incident, sometimes are done with zero notice. I would assume that the same approach is used worldwide.
 
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