Breadcrumb Home Frequently Asked Questions Audits FAQs Under what circumstances would an MDSAP audit be followed by an RA inspection? Under what circumstances would an MDSAP audit be followed by an RA inspection? An RA inspection may be required if: An MDSAP audit report failed to provide evidence required to support market authorization decisionsAn audit reveals public health safety concerns or fraudulent activityCombination product device manufacturers may still require RA audits/inspections. Additional guidance on combination products is available hereSome situations when the manufacturer is currently subject to regulatory action (see ‘Manufacturers’ for further information).