Is company “A” a contract manufacturer, a labeler, or a repackager

#1
I work for the parent company who manufactures a medical device.
Company “A” purchases bottles, caps, packaging for the parent company and stores them. Upon request, company “A” will send bottles and caps to a laboratory who fills the bottles, caps them, and sends the bottles back to company “A” in bulk form. Company “A” then re-packages the bottles into smaller quantity packages and sends the packages off to customers.
Is company “A” a contract manufacturer, a labeler, a repackager???
Thanks very much.
 
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Ronen E

Problem Solver
Staff member
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#2
I work for the parent company who manufactures a medical device.
Company “A” purchases bottles, caps, packaging for the parent company and stores them. Upon request, company “A” will send bottles and caps to a laboratory who fills the bottles, caps them, and sends the bottles back to company “A” in bulk form. Company “A” then re-packages the bottles into smaller quantity packages and sends the packages off to customers.
Is company “A” a contract manufacturer, a labeler, a repackager???
Thanks very much.
Hello and welcome to the Cove :bigwave:

Unless someone else’s name and contact is on the final primary packaging (smaller containers) label, “A” is none of the above but an ordinary Manufacturer (this includes an assumption that the very same bulk, labelled bottles are not also offered to end-users as a finished device, by an entity other than “A”).
 
#3
Thanks very much for the reply.
The finished product references the parent company. Company "A" is not referenced anywhere on the product / packaging.
 
#5
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.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
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)
 
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