Consulting

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 ensure 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 management 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 regulations. 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 inspections. The positive finding is probably impossible. 483 charts with no criticism (only observation) are perfect. However, certain enterprises may receive 438 charts with criticism, in the other words, it result in Warning letter Automatic Detention QSR Hold and Recall that abolish the permission of entering American market permanently.
American medical device factory inspection is also one of the strictest inspective methods in the medical device quality management system. The objectives are enterprises who import medical device into America, including American and foreign manufacturers. Inspectors will be sent to medical device actual producing places by American FDA , inspecting factories strictly to ensure whether the factories meet QSR regulations or not.
FDA factory inspection will not charge or issue any certificate.
Osmunda medical device service group provides consulting service of FDA factory inspection. Welcome to call us.