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Sonali Gunawardhana Discusses FDA Inspections of Medical Device Manufacturers

Bloomberg BNA’s Medical Devices Law & Industry Report
November 12, 2015

Sonali P. Gunawardhana, of counsel in Wiley Rein’s Food & Drug Law Practice, was quoted by Bloomberg BNA’s Medical Devices Law & Industry Report in a November 11 article about U.S. Food and Drug Administration (FDA) inspections of medical device manufacturing facilities.

The article cited a report from the FDA’s Center for Devices and Radiological Health, which shows a steady increase in the number of international inspections performed by the agency. The report also indicates that foreign inspections are more likely than domestic inspections to result in some type of Quality System Regulation (QSR) violation, Ms. Gunawardhana said.

Data collected from 2008 to 2014 revealed that 58% of foreign device manufacturers were not fully compliant with the QSR, compared with 48% of domestic manufacturers. The report also shows that corrective and preventive action (CAPA) violations were among the QSR violations most frequently cited by the FDA.

“Things are pretty much status quo in the world of QSR inspections,” Ms. Gunawardhana said. “The big area remains inadequate CAPAs across the board for both domestic and foreign facilities.”