Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the agency will focus like a laser on CAPA.

The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs.

In a June 30, 2016, warning letter, the agency zeroed in on the CAPA program at TriMed, a manufacturer of implantable bone fixation systems based in Santa Clarita, California. Long story short: It didn’t like what it found. Here’s why:

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