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Audit Question Stage 1 with FDA compliance
I recently had a client going through Stage 1 and the registration auditor commented on their procedures containing a reference to the CFR 820 as it pertains to their organization as a Distributor and a Servicer. They also were told they need to take an exclusion to Medical Device Reporting, it is not a requirement for a third party servicer, however it is required they have a documented process to record any adverse reporting. The auditor suggested this leaves them open for a more in depth "Audit". However - they distribute, install, service and repair the medical device. FDA would most likely audit this procedure if they were to come to their facility. Has anyone ever had an auditor from the registrar comment on this?
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