My company distributes a class I medical device in the USA that we receive from the Initial Importer. It does carry our name such as, "Manufactured for Company XYZ" to show the exact nature of this relationship. We've had issues with the Initial Importer and further upstream, the non-compliance gaps to various parts of the QSR with respect to the manufacturer. We have been trying to resolve these issues with the manufacturer, albeit somewhat unsuccessfully. Although I know that these need to be resolved, I have always argued that strictly from a regulatory responsibility, we are exempt from 21CFR820.50 Purchasing Controls. My basis is that since we are a distributor of this device, we are not part of the definition, manufacturer, as articulated in 21CFR820. However, my company is also a registered manufacturer of medical devices where these regulations obviously do apply. Can I rightfully take the stance that we are exempt from Purchasing Controls with respect only to this private branded distributed device?