Regulatory Open Forum

The company I currently work for is getting ready to purchase a finished product from another company to send with some of our instruments.  This is the first time that we will be purchasing a product from another company without labeling it as our own.  Does anyone else's company do this and what are your suggestions for tracking and inspecting these products?  

Thank you, 
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Bobbi Siddoway
Salt Lake City UT
United States
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Since you are indirectly guaranteeing or recommending the product by distributing it,, I would suggest you handle it similar to a private label even if your name is not on it. If regulated, make sure they have the correct clearances or approvals for where you market.

Perhaps a supplier or quality audit of them? Also, consider some level of quality agreement with them to agree on who handles complaints and how complaint information is communicated and resolved between the companies and customers.
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Ginger Cantor RAC
Centaur Consulting LLC, Owner and Principal Consultant
River Falls WI
United States
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Original Message:
Sent: 5/4/2015 3:39:06 PM
From: bsiddoway@tjoinc.com
Subject: Purchased Finished Products

The company I currently work for is getting ready to purchase a finished product from another company to send with some of our instruments.  This is the first time that we will be purchasing a product from another company without labeling it as our own.  Does anyone else's company do this and what are your suggestions for tracking and inspecting these products?   Thank you,  ------------------------------------------- Bobbi Siddoway Salt Lake City UT United States -------------------------------------------

Ginger, 

Thank you!  Just a few more questions, this is a Class I instrument that will added to our instrument cases which we do not sell but instead consign out to our Physicians.  The instrument is intended to attach to one of our instruments.  Would you add a fit check inspection?  Will we need to do a design change in order to add to our instrument case?  Are there any other processes you would include for this?

Thank you, 

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Bobbi Siddoway
Salt Lake City UT
United States
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Original Message:
Sent: 05-05-2015 07:52
From: Ginger Cantor
Subject: Purchased Finished Products

Since you are indirectly guaranteeing or recommending the product by distributing it,, I would suggest you handle it similar to a private label even if your name is not on it. If regulated, make sure they have the correct clearances or approvals for where you market.

Perhaps a supplier or quality audit of them? Also, consider some level of quality agreement with them to agree on who handles complaints and how complaint information is communicated and resolved between the companies and customers.
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Ginger Cantor RAC
Centaur Consulting LLC, Owner and Principal Consultant
River Falls WI
United States
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Interesting discussion.   What if the purchased finished good were an OTC drug product?  How would distributorship differ from the role of manufacturer?

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Debra Weigl
Oklahoma City OK
United States
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Original Message:
Sent: 05-05-2015 11:09
From: Bobbi Siddoway
Subject: Purchased Finished Products

Ginger, 

Thank you!  Just a few more questions, this is a Class I instrument that will added to our instrument cases which we do not sell but instead consign out to our Physicians.  The instrument is intended to attach to one of our instruments.  Would you add a fit check inspection?  Will we need to do a design change in order to add to our instrument case?  Are there any other processes you would include for this?

Thank you, 

-------------------------------------------
Bobbi Siddoway
Salt Lake City UT
United States
-------------------------------------------


Original Message:
Sent: 05-05-2015 07:52
From: Ginger Cantor
Subject: Purchased Finished Products

Since you are indirectly guaranteeing or recommending the product by distributing it,, I would suggest you handle it similar to a private label even if your name is not on it. If regulated, make sure they have the correct clearances or approvals for where you market.

Perhaps a supplier or quality audit of them? Also, consider some level of quality agreement with them to agree on who handles complaints and how complaint information is communicated and resolved between the companies and customers.
-------------------------------------------
Ginger Cantor RAC
Centaur Consulting LLC, Owner and Principal Consultant
River Falls WI
United States
-------------------------------------------

Hi Debra.

My initial thought on this would be the result of the review would be similar.  An OTC just like a Class I needs to be traceable and therefore, you are essentially taking on the distribution role in the equation.  As a distributor under 21 CFR 210 and 211 you have responsibilities for keeping records and allowing FDA access to those records during inspections.  So in my opinion you would want a quality agreement, distribution agreement, and also routine quality audits (or access to information on quality audits performed by the manufacturer at least) and essentially deal with this as if you were a private label customer of the company manufacturing the OTC.

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Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
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Original Message:
Sent: 05-06-2015 09:05
From: Debra Weigl
Subject: Purchased Finished Products

Interesting discussion.   What if the purchased finished good were an OTC drug product?  How would distributorship differ from the role of manufacturer?

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Debra Weigl
Oklahoma City OK
United States
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Original Message:
Sent: 05-05-2015 11:09
From: Bobbi Siddoway
Subject: Purchased Finished Products

Ginger, 

Thank you!  Just a few more questions, this is a Class I instrument that will added to our instrument cases which we do not sell but instead consign out to our Physicians.  The instrument is intended to attach to one of our instruments.  Would you add a fit check inspection?  Will we need to do a design change in order to add to our instrument case?  Are there any other processes you would include for this?

Thank you, 

-------------------------------------------
Bobbi Siddoway
Salt Lake City UT
United States
-------------------------------------------


Original Message:
Sent: 05-05-2015 07:52
From: Ginger Cantor
Subject: Purchased Finished Products

Since you are indirectly guaranteeing or recommending the product by distributing it,, I would suggest you handle it similar to a private label even if your name is not on it. If regulated, make sure they have the correct clearances or approvals for where you market.

Perhaps a supplier or quality audit of them? Also, consider some level of quality agreement with them to agree on who handles complaints and how complaint information is communicated and resolved between the companies and customers.
-------------------------------------------
Ginger Cantor RAC
Centaur Consulting LLC, Owner and Principal Consultant
River Falls WI
United States
-------------------------------------------

Hello Bobbi

Yes I'd consider some type of fit check. You can contact me with more questions at centaurconsultingllc@gmail.com.
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Ginger Cantor RAC
Centaur Consulting LLC, Owner and Principal Consultant
River Falls WI
United States
-------------------------------------------



Original Message:
Sent: 5/5/2015 11:09:29 AM
From: bsiddoway@tjoinc.com
Subject: RE: Purchased Finished Products

Ginger,  Thank you!  Just a few more questions, this is a Class I instrument that will added to our instrument cases which we do not sell but instead consign out to our Physicians.  The instrument is intended to attach to one of our instruments.  Would you add a fit check inspection?  Will we need to do a design change in order to add to our instrument case?  Are there any other processes you would include for this? Thank you,  ------------------------------------------- Bobbi Siddoway Salt Lake City UT United States -------------------------------------------
Original Message: Sent: 05-05-2015 07:52 From: Ginger Cantor Subject: Purchased Finished Products Since you are indirectly guaranteeing or recommending the product by distributing it,, I would suggest you handle it similar to a private label even if your name is not on it. If regulated, make sure they have the correct clearances or approvals for where you market. Perhaps a supplier or quality audit of them? Also, consider some level of quality agreement with them to agree on who handles complaints and how complaint information is communicated and resolved between the companies and customers. ------------------------------------------- Ginger Cantor RAC Centaur Consulting LLC, Owner and Principal Consultant River Falls WI United States -------------------------------------------

Hi Bobbi,

In my opinion your company has become a distributor of the purchased product. You'll then need to fulfil to all requirements for distributors. Each distributed device must be traceable. Also be aware of vigilance requirements.

As Ginger outlined a quality agreement with your vendor can be considered.
Please also consider a distribution agreement with your vendor, since the vendor will be responsible for registration of the product in case the product will be sent abroad.

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Paul Kooijmans
Regulatory Affairs manager
Eurotrol B.V.
Ede
Netherlands
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Original Message:
Sent: 05-04-2015 15:39
From: Bobbi Siddoway
Subject: Purchased Finished Products

The company I currently work for is getting ready to purchase a finished product from another company to send with some of our instruments.  This is the first time that we will be purchasing a product from another company without labeling it as our own.  Does anyone else's company do this and what are your suggestions for tracking and inspecting these products?  

Thank you, 
-------------------------------------------
Bobbi Siddoway
Salt Lake City UT
United States
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