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.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#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)
 
Thread starter Similar threads Forum Replies Date
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
D Can A Contract Manufacturer Be One In The Same Company? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
U Internal auditing - Company employees or contract second party Internal Auditing 10
M 7.5.2 Exclusion in a Contract Procurement Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
GStough "Outsourced Processes" in a Government Contract Service Provider Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Document Control: Contract between my company and customer Document Control Systems, Procedures, Forms and Templates 4
I Contract Manufacturing Company - What does contract manufacturing company mean? Other Medical Device and Orthopedic Related Topics 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
L Have been purchased by a corporate company ISO 13485:2016 - Medical Device Quality Management Systems 7
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S Malcolm Baldrige Company Dashboard Quality Tools, Improvement and Analysis 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
R MDEL and company affiliate Canada Medical Device Regulations 0
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Audits in a tiny Dx Company Internal Auditing 33
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Implementing the PRRC role in a company EU Medical Device Regulations 7
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 18
qualprod Corona virus Contingency plan - What have you done in your company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Client Communication - SaaMD company Misc. Quality Assurance and Business Systems Related Topics 3
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4

Similar threads

Top Bottom