Sending Partially Labeled Product to Korea

S

sunnybrook

Good day! I have had a rather unusual request from our Korean distributor. Apparently they failed to notify their FDA of a change to our sterilization method - we swtiched from gamma to EO several years ago. They are preparing for an inspection and have asked me to send product with a label saying it was gamma sterilized. I of course said I can't do that. Now they have asked that I send inner packages only with just the lot number on them. I was just wondering if there is some way I can help our Korean distributor without violating labeling requirements. I have offered to send all the new validation data for EO, but they keep insisting on blank pouches - no doubt to put their own gamma labels on. Any advice on how I should handle this?
 
Ronen E

Ronen E

Problem Solver
Moderator
sunnybrook said:
Good day! I have had a rather unusual request from our Korean distributor. Apparently they failed to notify their FDA of a change to our sterilization method - we swtiched from gamma to EO several years ago. They are preparing for an inspection and have asked me to send product with a label saying it was gamma sterilized. I of course said I can't do that. Now they have asked that I send inner packages only with just the lot number on them. I was just wondering if there is some way I can help our Korean distributor without violating labeling requirements. I have offered to send all the new validation data for EO, but they keep insisting on blank pouches - no doubt to put their own gamma labels on. Any advice on how I should handle this?
Click to expand...

Hi,

IMHO, this is a legel issue more than anything else. The question is whether or not you want to allow misbranding (regardlless of whether or not you are legaly accountable).

Soeey I can't really help.
Ronen.:(
 
M

MIREGMGR

If you play along, and your expectations of their actions prove to be correct, your company will be legally accountable here in the US.

I wouldn't touch a request like this with a ten foot pole...so to speak.

Perhaps you need to (conveniently) have "production issues that prevent you from supplying them with product for a while". Meanwhile, starting after their inspection, they'd have the time to play catch-up regarding their regulatory stance "for the planned sterilization method change on the anticipated return of the product to availability".
 
S

sunnybrook

thanks, everyone. I was pretty sure there wasn't anything I could do to help them, but I thought I would check.
 
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