FDA Audit - who is "eligible"? Medical Device Sub-Contract Manufacturer

D

dletteri

#11
Re: FDA Audit - who is "eligible"?

Chris,

You've just summed up my confusion. I was told that this is a "routine inspection" ... not triggered by a customer audit or any type of device approval.

Now, could it be because we *were* registered, until the FDA changed their rules a couple of years back to eliminate registration for contract manufacturers, and we're simply still on their radar?

Dave
 
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M

MIREGMGR

#12
I think the earlier assumption was that you were asking if they could inspect you, issue a 483 to you identifying failures on your part to conform to requirements, and obligate you to take corrective actions and report those actions to them for acceptance or rejection.

It's clear that they cannot demand that you conform to rules to which you are regulatorily not subject. If they insist you are subject to them, there may be some information that isn't part of this thread that is affecting FDA's view of your Manufacturer status.

If on the other hand what you're asking is literally can they demand to enter your plant and look around, the legal answer probably is yes. FDA inspectors are sworn law officers, badges and all. Part of their job is to find outfits that make medical devices but haven't registered. They can't very well do that if they can't investigate an otherwise-unknown operation that's clearly making something medical.

You can of course literally refuse them entry on a given day, but I wouldn't advise that. They may well come back the next day, or even the same day, with (1) a really bad attitude and (2) armed federal marshalls and a search warrant.
 
M

MIREGMGR

#13
Re: FDA Audit - who is "eligible"?

Now, could it be because we *were* registered, until the FDA changed their rules a couple of years back to eliminate registration for contract manufacturers, and we're simply still on their radar?
Are you in the database at this page, listed as anything but a Contract Manufacturer?
 

RCW

Quite Involved in Discussions
#14
Dave,

My company is similar to yours with the exception that someone here registered with the FDA years ago.

Probably when your customer was audited, your company's name was given as the subcontractor and the FDA is finally getting around to paying you a visit.

Bottom line: Even though your name isn't on the product and you don't distribute it, your are still eligible for a visit from the FDA simply because you are building a medical device. You are a lot less liable than the actual owner / distributor of the device, but there is still some risk for your company.

:topic: I got more logical, practical opportunities for improvement from my last FDA audit than I did from my last 3 customer audits combined! For being the big, bad FDA, I have enjoyed working with most of the investigators who have come in here.
 
C

Chris Ford

#15
Re: FDA Audit - who is "eligible"?

Chris,

You've just summed up my confusion. I was told that this is a "routine inspection" ... not triggered by a customer audit or any type of device approval.

Now, could it be because we *were* registered, until the FDA changed their rules a couple of years back to eliminate registration for contract manufacturers, and we're simply still on their radar?

Dave
Hi Dave,

I suppose that's entirely possible. If you were registered as a manufacturer, but you're not now, they'll confirm your status during the inspection.

In general, though FDA does have jurisdiction, and can inspect the facility.
 
G

gar4guv

#16
In a former life, I used to do these inspections. It was not uncommon to go into a contract manufacturer. The only time I did not do a full inspection was if I found out they were a component manufacturer only.

It was kind of a simple rule for us, if a finished device or accessory leaves the facility (labeled or not) then the site falls under FDA jurisdiction. Even with the component makers we still had to look around to determine if that's all they are doing. We weren't allowed to just take the owners word for it.
 
G

gar4guv

#18
Here is the official definition of a finished device.

Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized

In other words, if it functions, its finished.
 
D

dletteri

#19
No, no - we certainly wouldn't refuse them entry.

Your initial assumption is correct. We *were* registered as a contract manufacturer, but since the rules changed a few years back, we have no longer been registered. We are still clearly a Contract Manufacturer, as defined on the FDA website. We do not "manufacture or distribute" ... we produce product to the manufacturer's specifications, and ship only to them. I think that we just never got taken off of their audit schedule.

So, are you saying that, in your opinion, since we are not registered, we would not have to legally respond to any 483s, etc., if any were issued?
 

RCW

Quite Involved in Discussions
#20
So, are you saying that, in your opinion, since we are not registered, we would not have to legally respond to any 483s, etc., if any were issued?
Sure....don't respond to 483's, especially if you don't want to make medical devices anymore.

This isn't about being registered or not. You are a subcontracted manufacturer of medical devices. PERIOD! You fall under the FDA's realm of investigation.

Personally, I don't see what the problem is about being audited. As a subcontractor, I've been averaging an FDA audit about every 3 - 4 years. Geez, I've got some customers coming in here a couple times a year to do their audits.
 
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