AmericanFDAisapublichealthandservicesdepartmentofthestatedepartment.Everyyear,thousandsofinspectorsinFDAaresentto15000factoriesoverseatoexaminewhethertheiractivitiesaccordwiththestandard.FDAfactoryinspectionisthemedicaldeviceproductioninvestigationofAmericanFDAaswellasthestrictestinspectivemethodinthemedicaldevicequalitysupervisionsystem.FDAqualitysystemregulationinspectionfactory,passingtheinspectionofmedicaldevicecompaniesfromFDAofficials,makessurethatenterprisesmeetthequalitymanagementsystemrequirementsofrelevantlawsandregulati***.FDAinspectorsoftenapplyQSITtoinspectenterprises.FourmajorbranchsystemsarechosenbyQSITplan:correctionandpreventedmeasures,designandresearchcontrol,productandprocesscontrolandgeneralcontrol.Differentlevelsofinspectionwillselectdifferentbranchsystems(eg:supervisionorgeneralinspection).Asfarasforeignenterprises,thefirstfactoryinspectionincludesfourgeneralinspecti***.Thepositivefindingisprobablyimpossible.483chartswithnocritici***(onlyobservation)areperfect.However,certainenterprisesmayreceive438chartswithcritici***,intheotherwo***,itresultinWarningletterAutomaticDetentionQSRHoldandRecallthatabolishthepermissionofenteringAmericanmarketpermanently.)