Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device

#1
My company is looking to distribute a medical device that we are not the legal manufacturer of. We currently review labels and certificates (CoCs, sterilization records, etc.) from the supplier. The supplier is on our Approved Supplier List and is routinely audited. There has been some pushback from management and the receiving team that we are not required to perform an incoming inspection for the purchased finished goods since the supplier has performed inspection activities prior to shipping to us.

I agree it would be redundant to inspect the products when we receive them but I beg to differ based on:
  • FDA 820.80 - Receiving, in-process, and finished device acceptance
  • FDA 820.120 - Device Labeling

What are the requirements for us as the distributor for incoming inspection?

Thank you for your help.
 
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