CDRH Data Shows 30 Percent Hike in Foreign Inspections

FDA investigators conducting quality system inspections are becoming a more common sight at international facilities, according to new numbers unveiled in late 2015 by the agency’s device center.

Indeed, inspections at foreign manufacturers jumped by more than 29 percent between 2013 and 2014, from 460 to 594. Meanwhile, those conducted at domestic sites increased only slightly, the Center for Devices and Radiological Health says.

CDRH released the data to demonstrate its commitment to transparency and the Case for Quality initiative, the center adds.

China led the top five locations last year with 190 inspections, followed by 72 in Germany, 37 in Japan, 29 in Taiwan and 25 in Switzerland, according to the data.

In terms of warning letters and 483s, production and process controls and corrective and preventive actions continue to be the most frequently cited issues, the FDA says.

The number of warning letters with quality system citations issued by the FDA actually decreased, dropping nearly 16 percent from 144 in 2013 to 121 in 2014. Nearly 63 percent of the warning letters issued in 2014 went to domestic companies.

Quality systems surveillance inspections resulted in the FDA issuing a Form 483 roughly 47 percent of the time at domestic sites, versus roughly 57 percent at foreign sites in 2014.

Stay up to date on regulatory stories like this one by subscribing to International Devices & Diagnostics Monitor. As countries around the globe are constantly changing the rules on medical devices and diagnostics, IDDM is the one-stop resource that brings you a complete, global picture of the medical device regulations that affect your business.