What happens after the establishment inspection report (EIR) is completed by the field staff?
There are several potential outcomes from an inspection: • If FDA concludes that there are no objectionable conditions or practices with the manufacturing operations, or any that do not justify further regulatory action, i.e., a No Action Indicated (NAI) result, then OC/FOB will notify ODE POS that the PMA approval can proceed from a manufacturing operations perspective. • If FDA concludes that there are objectionable conditions or practices, but these do not warrant administrative or regulatory action, i.e., a Voluntary Action Indicated (VAI) result, then FDA may communicate the objectionable conditions or practices to the applicant and recommend that the applicant voluntarily correct the deficiencies. FDA may evaluate the corrections during a subsequent inspection. As above, OC/FOB will notify ODE POS that the PMA approval can proceed from a manufacturing operations perspective. • If FDA concludes that there are objectionable conditions or practices that warrant regulatory or adminis
