American FDA is a public health and services department of the state department. Every year, thousands of inspectors in FDA are sent to 15000 factories oversea to examine whether their activities accord with the standard. FDA factory inspection is the medical device production investigation of American FDA as well as the strictest inspective method in the medical device quality supervision system.
FDA quality system regulation inspection factory, passing the inspection of medical device companies from FDA officials, makes sure that enterprises meet the quality management system requirements of relevant laws and regulati***. FDA inspectors often apply QSIT to inspect enterprises. Four major branch systems are chosen by QSIT plan: correction and prevented measures, design and research control, product and process control and general control. Different levels of inspection will select different branch systems (eg: supervision or general inspection). As far as foreign enterprises, the first factory inspection includes four general inspecti***. The positive finding is probably impossible. 483 charts with no critici*** (only observation) are perfect. However, certain enterprises may receive 438 charts with critici***, in the other wo***, it result in Warning letter Automatic Detention QSR Hold and Recall that abolish the permission of entering American market permanently.