Difference in repacker and relabeller

This query is : Resolved

Querist : Anonymous

Querist : Anonymous (Querist)

25 December 2017 Dear all,

One of my friend wants to obtain FSSAI license (He sells chai patti in packaged polythene).
He obtains chai- patti from market and packs the chai patti in packages of 100 and 500 grams.
So for the sake of obtaining registration what should one select in between REPACKER and RELABELLER.
Also note that on the package he doesn't mention any brand name and if he wants to print name in future than what should be the treatment.

Thanks & Regards

Arpit Shah

Arpit Shah (Expert)
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26 December 2017 FDA definition fo a Repackager: Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

This what we want to do at our warehouse:

1) Vendor sends a shipping case with 50 qty of a Class II device to our warehouse.

2) Warehouse breaks down the bulk shipping case, and then packs 10 qty in a shipping case for shipment to the customer.
Shipping case has our company label with our internal PN and Lot #, and a description of the contents.

3) Warehouse does not change the device packaging or its use instructions.