I agree with MIREGMGR. I had the same questions while I was working on a
510K....My company designs products for another company and we have the products manufactured at a total different company. Though, the company we design the product for basically puts their name on the product and is repsonsible for marketing and complaints...they are still subjected to PORTIONS of 21 CFR 820. My company is the one that files with the FDA and maintains a QS, however, since the other company contributes by handling labeling, complaints and servicing records, this company also need to be linked within our QS....even if we control it. I had discussed this with the FDA for the same concerns as you. So, as MIREGMGR said, "Certainly the FDA can inspect them if it determines doing so is necessary to verify that the operations they perform are being effectively controlled by you" and I would take a look at what processes the CM is responsible for and how that links to your QS.