News Feature | March 18, 2016

FDA Device Inspections Decline In 2015

By Jof Enriquez,
Follow me on Twitter @jofenriq


The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) said it conducted fewer medical device inspections overall during 2015 than in 2014.

Based on FDA’s Field Accomplishment and Compliance Tracking System (FACTS), the overall number of Quality Systems (QS) inspections between Jan. 1, 2015 and Dec. 31, 2015 totaled 2,104 inspections, 5 percent fewer than in 2014, when the agency conducted 2,213 inspections, according to the 2015 Annual FDA Medical Device Quality System Data report.

For 2015, U.S. domestic inspections fell 9 percent to 1,484, while foreign inspections rose 5 percent to 620, compared to 2014. It's the fifth straight year that saw the number of U.S. inspections drop. The trend is reversed for foreign inspections, which increased for the eighth consecutive year. The number of foreign inspections grew from 594 in 2014 to 620 in 2015, almost triple the number of inspections conducted in 2008.

"The agency has been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly," FDA said in the report.

For 2015, China topped the list of foreign inspection locations, with 126 inspections conducted. It was followed by Germany and Japan, with 90 and 44 inspections, respectively. The same three countries received the most FDA inspections during 2014, as well. 

CDRH sent 121 warning letters for 21 CFR 820 QS regulation deficiencies, in 2015 — exactly the same number sent during 2014, according to FDA’s Warning Letters and FDA’s Compliance Management System (CMS). This was down from 144 warning letters sent in 2013, and 164 warning letters sent in 2012.

Based on FDA’s Turbo Establishment Inspection Reporting (EIR) Database, in 2015, the agency issued 924 Form 483s and 3,525 Form 483 observations, cited for 21 CFR 820 QS regulation deficiencies.

"Production and Process Controls and Corrective and Preventive Actions continue to be the most frequently cited QS subsystems," said the FDA.

Broken down into QS subsystems, Production and Process Controls (P&PC) had 1141 observations; Corrective and Preventive Actions (CAPA) had 1131, Design Controls (DES) had 536, Document Controls (DOC) had 339, and Management Controls (MGMT) had 378.

While the figures generally have been steady for most QS subsystems since 2008, worth noting is the significant drop in management responsibility enforcement actions, which last year dropped to less than half of what they were a decade ago, its lowest point since 2004.

"The QS regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use" and provides "a framework for device manufacturers to follow and gave them greater flexibility in achieving quality requirements," the agency explains in the report, which is released annually as part of the FDA’s Transparency and Case for Quality Initiatives program to assist device manufacturers improve medical device quality, identify areas of concern, and  avoid receiving warning letters.