Contract Manufacturer must adhere to 21 CFR 820 - Can FDA require us to do this?

M

MIREGMGR

#11
Re: Can FDA require us to do this?

Loosely- or un-controlled process changes on Class II devices are always problematic. It could have been worse...they could have found that the process changes amounted to potentially significant product changes for which a new 510(k) would be required to re-prove that the product still was safe and effective, and substantially equivalent to a legally marketed predicate device or otherwise entitled to marketing approval.

Which is what I am SO UPSET AND CONFUSED about.
Current FDA policy is to rely upon the finished device manufacturer to assure that components are acceptable for use.
Presumably the inspector felt, after the initial part of your audit, that the documentation of that assurance was substantially inadequate. That's the trigger for upstream inspections... which are done not to audit the vendors, who (mostly) are not legally encompassed by FDA authority, but rather as an extension of their audit of you.

The FDA has legal authority to inspect anybody and everybody that participates in your medical device creation process, if they determine such inspections are needed. That's one of the differences between the FDA and 13485. It's related to the fact that the FDA folks have badges, and can call in the federal marshalls if they need them. But, they can't (except in extraordinary circumstances) shut down your non-registered suppliers, or apply civil penalties to them. They do have that level of authority over you, on the other hand.

I'm sure it'll get straightened out.
 
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Weiner Dog

Med Device Consultant
#13
Re: Can FDA require us to do this?

Unless things dramatically changed since I left FDA in 2006 (been with FDA for over 21 years), FDA does not have the legal authority to inspect anybody and everybody that participates in a medical device creation process, if they determine such inspections are needed. FDA only inspects "finished medical device" manufacturers, distributors, and initial importers. "Manufacturer" includes manufacturers, contract manufacturers, specification developers, re-manufacturers, repackers, and relabelers. Contract manufacturing of components (unless special components like blood tubing, which can be seperately sold) are the responsibility of the manufacturer, specification developer, etc. under purchaing controls.
 
M

MIREGMGR

#14
We've been told in the past that if the FDA concludes that a product marketer (being either a manufacturer or a specification developer) may be marketing an adulterated product, and the possible adulteration may be occurring due to actions taken or not taken by a contract manufacturer and cannot be readily determined other than by inspection, the FDA can inspect that contract manufacturer to obtain information it needs to protect health and safety with respect to the marketer's product(s).

The circumstances as described by JayJay in the original post either are consistent with that understanding, or perhaps are explainable via some other circumstantial interpretation.

Whatever the theoretical permitted scope of FDA contract manufacturer inspections, one thing we do know is that JayJay's employer's contract manufacturer was inspected as a result of an FDA determination during his employer's inspection that cause for such an inspection existed. That must be explainable somehow.
 
M

maxenix

#15
See QSR Manual - Quality System Regulation "contract Manufactures“
: Depending on the circumstances,both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.
So if you call Company "B" is "contract manufactures", there is no fault for FDA inspecting Company "B" .
But actually Company "B" only manufactures components as you say, so i think you confuse the "component manufacturers" and "contract manufacturers", Component manufacturers are excluded from the Qs regulation by 820.1(a)(i).so very important thing you must do now is to make it clear.
 
J

JayJay

#16
Re: Can FDA require us to do this?

What additional operations are performed after you receive the "component"? If none other than packaging, they are not a component mfr, but a contract mfr.
We inspect all components, assemble them together to create the finished device, package and ship them.
 
J

JayJay

#17
See QSR Manual - Quality System Regulation "contract Manufactures“
: Depending on the circumstances,both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.
So if you call Company "B" is "contract manufactures", there is no fault for FDA inspecting Company "B" .
But actually Company "B" only manufactures components as you say, so i think you confuse the "component manufacturers" and "contract manufacturers", Component manufacturers are excluded from the Qs regulation by 820.1(a)(i).so very important thing you must do now is to make it clear.
I did use the term "contract manufacturer" incorrectly. Our manufacturer, with whom we have a contract, is a component manufacturer by FDA definition. Our relationship with the component manufacturer is as follows:

1. We design all of our products, and maintain the DHF
2. We give all design specifications for all product components to our manufacturer
3. The manufacturer fabricates all components
4. The manufacturer sends all of the components back to us
5. We inspect 100% of all parts, assemble, and ship all products
6. We maintain the customer complaint file (currently ZERO for last 4 years!)
7. We maintain a contract with the manufacturer outlining their responsibilities for fabricating the components, as well as referencing our DMR for the acceptance criteria for the related products.

Given FDA definitions http://www.fda.gov/cdrh/qsr/01qsreg.html, it seems as though the key difference between a contract manufacturer and a component manufacturer is that a contract manufacturer fabricates a finished device, and a component manufacturer does not.
 
M

MIREGMGR

#18
The OP's question was, I think, can the FDA inspect a component manufacturer that supplies a device maker, to gather information with regard to whether that device maker's product is compliant with 21 CFR 820 and whether that device maker is appropriately controlling the operations of that component maker.

A number of subsequent posts, it seems to me, have not clearly maintained the necessary distinction between the component maker being subject to FDA enforcement actions and penalties regarding their compliance with 21 CFR 820 regulation, and the device maker being responsible for the actions of the component maker.

A component maker can do whatever the heck they want, subject only to contractural controls negotiated with their customer. The FDA won't impose penalties on them, as long as they don't make or market finished devices or otherwise act as a device maker.

However, a device-maker customer of a component maker is fully responsible for that component maker's operations with regard to what that device maker buys from the component maker. For instance, per the Process Validation Guidance, manufacturing processes at that component manufacturer must be validated if 100% inspection of those components is not done by the device maker or if such inspection has not been proven by the device maker to be capable of assuring that, to the extent affected by the component in question, the finished product meets all design characteristics and quality attributes including specifications.

That's the point of contractural controls over suppliers...which is a clear 21 CFR 820 requirement.
 
G

Gerry Quinn

#19
JayJay,

You may want to consider your relationship with the machine shop to be an "outsourcing" relationship. (see ISO 13485:2003 4.1 which points to 7.4.1)

Gerry
 
T

treesei

#20
1. JayJay's employer is a device manafacturer because assembly work is manufacturing, to respond to his initiate message. The machine shop tough is a component manufacturer.

2. I agree that a component manufacturer is beyond the scope of 21 CFR 820. Normally the FDA will not inspect a component manufacturer.

3. My guess is that during FDA's inspection to Company A, some major incomplinace in supplier management was identified and this triggered the visit to the next door. Company A does have full responsibility to manage Company B. The FDA is paying more and more attention to supplier management. I fully understand JayJay's frustration but I think right now the most important thing is to fix the damage asap.

4. 100% inspection may not guarantee simplified validation. The FDA has guidance document that explains when a process must be validated. Most likely Company B is 9001 certified as a supplier to a device OEM. Process validation IS an ISO 9001 requirement.
 
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