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

J

JayJay

#1
Hi all,

I'm hoping to receive feedback from anyone who has dealt with the FDA before, as they have really put a kink in our business plan.

Short Version:

The FDA is telling us that even though our contract manufacturer does not produce a finished device that they are still required to adhere to 21 CFR 820, and they also audited that firm. FDA is also telling us that even though our CM is not required to register with FDA, they are still responsible for 21 CFR 820, AND subject to an audit.

Elaborated version:

I recently joined a specification provider company who specs out a Class II medical device; We'll call this company "A"

Company "A" sends their device component plans to company "B" ( the contract manufacturer) for fabrication. Company "B" returns the product components to company "A" for inspection, assembly, and shipping to our customers.

Company "B" only manufactures the components, and does not assemble or ship the finished devices to the end users.

Company "B" is literally next door to company "A", about 50 foot steps.

Company "A" does not manufacture anything, and only provides specifications, and then inspects and assembles all components prior to shipping.

We were recently audited by the FDA, and much to our dismay they walked next door after our audit and performed an audit on our contract manufacturer as well. Our contract manufacturer does not implement all of the requirements of 21 CFR 820 because they are only a machine shop, and they fabricate many other products besides ours. Because of the fact that many parts of the 820 reg were not implemented at our contract manufacturer, WE were given a warning letter.

In 21 CFR 820.1 (A) Scope I quote: "This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance"

We have an excellent supplier qualification and audit procedure in place, and we audit them TWICE a year to ensure that their process still conforms to our requirements.

When I spoke with the small business rep from the FDA, he informed me that our contract manufacturer is still regulated by 820, even though they aren't required to register.

HOW CAN THAT BE???? It clearly states in the scope of the regulation that it doesn't apply to component manufacturers.

Can someone please tell me if I am missing something here????

Any replies are MUCH appreciated.:thanx:

FDA ----> :argue:<----- ME
 
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M

MIREGMGR

#2
Re: Can FDA require us to do this?

Your description of the circumstances seems to be exactly by the book. They are not legally subject to 21 CFR 820. You are subject to 21 CFR 820 regarding their operations for you. If you and they, together, do not maintain proper controls over the extent of their operations with regard to the medical device work they do for you, you are responsible. Thus you get the Warning Letter.

That's the legal basis for contract manufacturing. You have full legal responsibility.

Note that if they were a registered Establishment for other reasons, but were still a contract manufacturer for you on this job, they might be held to have co-legal-responsibility with you because (in effect) they're supposed to know better, being a registered Establishment.
 
D

Duke Okes

#3
Re: Can FDA require us to do this?

My interpretation is that they actually do the manufacturing, so you should flow down the 820 requirements to them. Consider if you were doing the component manufacturing, how would the 820 requirements apply? These requirements should be passed on to the supplier as part of the contract.
 
J

jrdarnell2

#4
Re: Can FDA require us to do this?

Does your vendor qualification and management program hold them to GMP standards?
 
J

JayJay

#5
Re: Can FDA require us to do this?

Does your vendor qualification and management program hold them to GMP standards?
Our Vendor Qual only holds them to the GMP standards to the extent that would be required for production and process controls. We do have them keep a DHR for their side of the operation, and our DHR references their DHR by a serial number (so that we can keep them linked). However, we do not require them to maintain procedures for things like design controls.
 
J

JayJay

#6
Re: Can FDA require us to do this?

I guess what I'm mainly frustrated with is that FDA can still go and audit our manufacturer, even though we audit them through the QMS.

As a result of this, I am thinking we are going to need to re-perform our process validation, because the one that they had on their side was basically just an installation qualification. At the time, we didn't think we needed to do a full-blown validation on their side because we inspect 100% of their work. However, now that I'm going back through the regulations, it seems as though they would still be required to perform the validation because they don't actually inspect the devices.

This is frustrating... :bonk:

Any suggestions on how I could handle process validation for them?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Re: Can FDA require us to do this?

I guess what I'm mainly frustrated with is that FDA can still go and audit our manufacturer, even though we audit them through the QMS.
Types of Establishments Subject to the GMP

The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.
 
M

MIREGMGR

#8
Re: Can FDA require us to do this?

Did the Warning Letter identify specific elements of your controls in relation to the contract manufacturer that the inspector determined were inadequate?

I'd focus on fixing those items.

Did the FDA have a problem with your component or product manufacturing verification or validation? Chapter 4 of the QSR Manual ("Process Validation") discusses when a process must be validated. You said that you had been performing 100% inspection. Did the FDA determine that your inspection process was inadequate to assure consistent specification conformance?
 
J

JayJay

#9
Re: Can FDA require us to do this?

It also says:

Types of Establishments Exempt from GMP

Component Manufacturers
A "component" is defined by 21 CFR 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device." Component manufacturers are excluded from the QS regulation by 21 CFR 820.1 (a)(1). Current FDA policy is to rely upon the finished device manufacturer to assure that components are acceptable for use. Component manufacturers are not routinely scheduled for GMP inspections; however, FDA encourages them to use the QS regulation as guidance for their quality system.
When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation as detailed under Manufacturers of Accessories ."

http://www.fda.gov/cdrh/devadvice/32.html#establishments
Which is what I am SO UPSET AND CONFUSED about.
 
J

JayJay

#10
Re: Can FDA require us to do this?

Did the Warning Letter identify specific elements of your controls in relation to the contract manufacturer that the inspector determined were inadequate?
No, only that our parts are adulterated because the CM isn't 21 CFR 820 compliant.

Did the FDA have a problem with your component or product manufacturing verification or validation? Chapter 4 of the QSR Manual ("Process Validation") discusses when a process must be validated. You said that you had been performing 100% inspection. Did the FDA determine that your inspection process was inadequate to assure consistent specification conformance?
They didn't identify it in the warning letter, however they did bring it up in a discussion because our inspection process is subjective in some parts, and rather difficult to document, although we managed to do it.

One of the things we really got nailed for was the fact that when the FDA went over to our CM, one of their managers had paperwork for corrective action approval, from us, to change a tool type in the CNC's because it was breaking frequently; I believe they changed from carbide to high-speed steel on a roughing tool. We actually performed a part verification before we let them implement it, but it was never documented. They really didn't like that.
 
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