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21 CFR 803 malfunction detected during packaging - report?

#1
I am wondering if anyone can help clarify the following scenario:

I am a combination product applicant in the US and therefore need to comply with 21 CFR part 803.
The drug is my own, the device is purchased and co-packaged with the drug.

If I get a customer complaint regarding a device malfunction that could lead to death or serious injury, it is clear to me that I have to issue a malfunction report.

but what if I find the malfunction that could lead to death or serious injury during packaging of the combination product? I have to issue a supplier complaint, but do I also need to issue a malfunction report?
 
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#2
I am wondering if anyone can help clarify the following scenario:

I am a combination product applicant in the US and therefore need to comply with 21 CFR part 803.
The drug is my own, the device is purchased and co-packaged with the drug.

If I get a customer complaint regarding a device malfunction that could lead to death or serious injury, it is clear to me that I have to issue a malfunction report.

but what if I find the malfunction that could lead to death or serious injury during packaging of the combination product? I have to issue a supplier complaint, but do I also need to issue a malfunction report?

The malfunction at user end are reportable events, however the potentials detected during packing (the batch is not released to market), that is not a reportable event, because no harm occur yet. you have to take substantial steps to mitigate such risk.

if anyone can add more....thank you.
 
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