Re: Is company “A†a contract manufacturer, a labeler, or a repackager
Does the fact that Company "A" does NOT open any sealed medical device, they simply put the sealed device into an alternate package change anything?
Thanks very much.
Sorry, I misread earlier. I thought that the contents from the lab-filled bottles were being transferred by “A” to smaller containers / bottles bearing the parent company’s name.
Now I understand that “A” merely packs a certain (small) number of lab-filled and sealed bottles into a secondary package (a box?) bearing the parent company’s name. Did I get it right this time?
Either way, “A” is a Contract Manufacturer (in my opinion),
unless the “customers” “A” ships to are only distributors (never end-users) and the box(?) containing the “small number” of bottles is a shipping carton / logistics packaging or the likes, and those distributors sell the bottles from it without secondary packaging bearing anyone’s name. In that case the roles definitions would depend on whose name is on the bottles - if it’s the parent company, the lab would be the Contract Manufacturer and “A” would merely be a logistics arm of the parent company (I’m not 100% sure that this description of mine is regulatorily-accurate, but let’s please leave it at that for the moment, because I have a feeling that this is not the actual scenario - let me know if otherwise).
If end-users buy the (small number of) bottles inside a retail box bearing the parent company’s name, as packed by “A”, “A” is a Contract Manufacturer because they perform a manufacturing step (final product packaging) and provide a finished device, which carries the potetial of significant errors and failures that might affect the final device’s safety or effectiveness. I don’t think that “A” should be considered a Repackager because they don’t remove the device (liquid?) from its original packaging.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Who Must Register, List and Pay the Fee
This is a little ambiguous because of the term “bulk”. You’ve referred to a batch of bottles as “bulk”, but I think the FDA refers to the liquid mass (possibly in a larger logistics container) in this case. The reason for my opinion is a slightly different definition the FDA uses for drug repackaging:
FDA regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug.
https://www.fda.gov/downloads/Drugs/Guidances/UCM434174.pdf
(See p. 2, s. II A)
