Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

Inadequate corrective actions

An FDA investigation was conducted from January to February 2017 at a class II medical device manufacturer. The FDA laid out several concerns in its April 21, 2017, warning letter, noting areas of CAPA noncompliance.

Among other claims, the CDRH noted that CAPAs opened as far back as 2015 and 2016 did not have adequate corrective actions in compliance with the Title 21 CFR Part 820 Quality System (QS) Regulation.

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