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What to expect if FDA wants to inspect a Class 1 Medical Device Manufacturer

A

Aphel

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#1
#1
Dear all,

Can someone share some information regarding what to expect if FDA wants to inspect a class 1 device manufacturer?
Where should I expect FDA's focus during such an inspection?

Thank you in advance for your support!

BR Aphel
 
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Ronen E

Ronen E

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#2
#2
Re: Class 1 Device Manufacturer - FDA Inspection

Aphel said:
Dear all,

Can someone share some information regarding what to expect if FDA wants to inspect a class 1 device manufacturer?
Where should I expect FDA's focus during such an inspection?

Thank you in advance for your support!

BR Aphel
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