Contract Packager or Repackager? And can client assume responsibility?

suffusive

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I have a situation with a very small client who is an initial importer of a Class II non-sterile, individually-wrapped, single-use device.

They get this device supplied in retail boxes (over-the-counter) from the Contract Manufacturer which may include 20 single-use, individually-wrapped devices.

But there are some size variations to this device so they also take receipt of individually-wrapped single-use devices and mix different sizes in a box themselves for the convenience of end users which they then directly ship to homes via a subscription service.

The problem is that the client is currently outsourcing this activity to a non-profit and they'd love to keep this activity there. In any other industry this activity would amount to simple order fulfillment/the most basic packaging job ever, but unfortunately it seems like the facility performing this outsourced operation needs to be FDA registered as a Repackager with appropriate QMS/controls in place. This is never going to happen at a little non-profit shop and therefore they will have to move this business elsewhere.

Any advice on how to navigate this would be great. The only approach I could think of is this:
This particular device can be sold in individual form in vending machines so this "bulk" individually-packaged form is DEFINITELY finished device form. That said, the non-profit shop isn't really "Repackaging" since they are taking completely finished devices and putting them in the exact same packaging/labeling that the retail versions have, just with a different mixture of sizes. Inasmuch as this is true, could we argue that the non-profit shop is functioning as a Contract Packager or Distributor and not a true Repackager?

I was also trying to think of ways my client could control the process/assume regulatory responsibility for this off-site activity, if you have ideas or unique approaches along those lines please let me know!

Thanks,
~Josh
 
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