FDA On-Site Inspection - Raw Material Manufacturing (Medical Devices)

P

PMIN92618

#1
Does the FDA need to be contacted for a site visit if we are a contract manufacturer who will begin to manufacture raw materials?
We currently get raw materials from a supplier but for cost purposes our customer is interested manufacturing raw materials in house that will end up in final goods.
The raw material manufacturing site will be different to the final good assembly location.
 
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Ronen E

Problem Solver
Moderator
#2
Re: FDA on-site inspection - raw material manufacturing

Hi, I moved your post to a new thread (and another forum) because it wasn't directly related to the topic of the thread where you originally posted.

FDA never needs to be contacted for arranging on-site inspections. They initiate site inspections based on their own priorities and schedule.

From your description I don't see a reason why FDA would need to inspect your site immediately. Nevertheless, they will likely review the change in your next scheduled inspection, or as a follow up to an inspection of your client.

Of course if something will go seriously wrong with the subject device(s), you can expect to see them around...

Cheers,
Ronen.
 
Last edited:
#3
Re: FDA on-site inspection - raw material manufacturing

Does the FDA need to be contacted for a site visit if we are a contract manufacturer who will begin to manufacture raw materials?
We currently get raw materials from a supplier but for cost purposes our customer is interested manufacturing raw materials in house that will end up in final goods.
The raw material manufacturing site will be different to the final good assembly location.
I am not sure what the "raw material" is but if there is any Drug Master File associated with the raw material (for example, resins or colorants in the form of a DMF Type III), you will have to revise the DMF to reflect the changed location.

Please provide additional information.
 
P

PMIN92618

#4
Re: FDA on-site inspection - raw material manufacturing

Thanks Ronen and Ajit.
The raw material is silicone, we will be manufacturing diaphragms (injection molding). The Injection Molding facility will be different to the address FDA has listed as our contract manufacturing site. Does the FDA need to be notified because of the additional location?
:confused:
 
P

PMIN92618

#5
Re: FDA on-site inspection - raw material manufacturing

Update: Spoke with FDA rep- says need to ask DICE if the raw materials need to be registered. If they do not, no worries. If they do, the relationship between the two sites will determine if the additional location needs to be registered.

Raw materials need to be registered???

I mentioned we have the medical device registered. Currently ordering raw materials that go into the making of that registered device. Now thinking to switch from ordering raw materials to making our own raw materials.

Do you know what she meant?

Waiting to hear back from DICE also...
 

Ronen E

Problem Solver
Moderator
#6
Re: FDA on-site inspection - raw material manufacturing

Honestly, this is becoming confusing...

By making "raw materials" (silicone elastomers?) do you refer to the chemical formulation of the substances that feed into the moulding machine?

I'm also confused as to by who/where exactly that raw materials will be made. Is it a sub-entity of the CM, the CM's client (the finished device owner), or a 3rd party? Client-supplied ingredients are sometimes treated differently from "normal" outsourced ingredients.

In general raw materials such as silicone elastomer reagents don't need to be registered (colorants excluded), but they do need to be controlled by the manufacturer. I dare say that if you move from outsourcing those reagents to formulating them in-house you're going to introduce a significant change to the device design. That, in turn, might have a raft of regulatory consequences, depending (among other things) on the specific device ProCode classification and the requirements / exemptions that apply. I recommend a thorough, careful review of all relevant aspects before you decide to make such a change.
 
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