We manufacture components that are shipped to the customer who put the drug in it and commercially distributes as a finished medical device.
This customer has sent an email stating that there is a new expectation from FDA that suppliers should be independently assessed for 21 CFR Part 820.
We get audited independently for ISO 13485 but havent heard about FDA. I have asked for the FDA reference but has anyone heard about this new requirement?
I have not heard yet that FDA audits suppliers who supply only components. If suppliers manufacture Final assembly for customer, it requires FDA audit and usually audits every two years.
As far as I know, FDA works on its own timeline in terms of who is audited. If they have any “for cause” reasons, I expect they could visit a component supplier. Given their resources and the number of suppliers, it’s unlikely FDA will visit any component suppliers without some suspicion of egregious failures that put the public safety at risk.
It’s incumbent on the manufacturer of record to determine the extent to which they qualify and approve suppliers (including [contract] final assembly manufacturers). This generally includes on-site audits of the contract manufacturer.