Certificate of Compliance from a Sister Company for FDA 21 CFR 820 Exemption

N

novo_2368

#1
Hi,

I have just assumed the Quality Assurance manager at my company. We purchase most of our medical devices (mostly class I devices) from a sister company which completes a thorough inspection. Would a strongly worded certificate of compliance from the sister company exempt our company from inspection of devices received while still maintaining compliance with FDA 21 CFR 820?

Thanks for your help in this matter.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

I have just assumed the Quality Assurance manager at my company. We purchase most of our medical devices (mostly class I devices) from a sister company which completes a thorough inspection. Would a strongly worded certificate of compliance from the sister company exempt our company from inspection of devices received while still maintaining compliance with FDA 21 CFR 820?

Thanks for your help in this matter.
Hello and welcome to the Cove :bigwave:

820.80:

(b)Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.
Please pay attention to the bold type phrase (my emphasis).

Cheers,
Ronen.
 
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