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How to Prepare for an FDA Inspection

J

Julie O

#21
Any nominations?

I work mostly on the pre-market regulatory side, not with quality systems, but mostly my experience is of companies getting lulled into a false sense of security by NB audits. Whether this is because their NBs are not so tough, or because there can be significant differences between an FDA inspection and an ISO 13485 audit, I can't say for sure, but my instincts are that it's probably some of both.
 
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