To identify domestic and foreign manufacturers who are not in compliance with the Quality System regulation. To identify manufacturers and importers who are not in compliance with the Medical Device Tracking regulation. To identify firms who are not in compliance with the Registration and Listing regulation.
Many large firms have several manufacturing facilities located in more than one district.
The above guidance is NOT applicable to Pre-Approval inspections. Many large firms also have design facilities located in sites that were previously not required to register. Sterilization is now covered as a part of the QSIT inspection under this compliance program. For guidance, see the Intercenter Agreement between the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, dated October 31, 1991. The Field Workplan for Inspection of Medical Device Manufacturers provides for inspection of half of each inventory of high risk devices and 40 percent of manufacturers of Class III devices.