J
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.
FDA ---->
<----- ME
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.

FDA ---->
<----- ME
