If a manufacturing site is already under regulatory action with an MDSAP RA, can they participate in the MDSAP?
If a manufacturing site is already under regulatory action with an MDSAP RA, can they participate in the MDSAP?
There are no exclusion criteria regardless of the past audit/inspection history, and regardless of the type of medical devices manufactured by the organization. Nevertheless, if a manufacturer had a previously unfavorable audit or inspection by an MDSAP RA, this RA may still choose to conduct a follow-up inspection.