CAPAs, Change Controls Spell Trouble for Medtronic Unit

Several issues with CAPA investigations and change controls netted a warning letter for TYRX, a Medtronic subsidiary that makes absorbable antibacterial envelopes.

For example, the Monmouth Junction, N.J., company had no procedures to control and take action on devices suspected to have nonconformities, according to the June 2 warning letter posted online June 21.

It cited the company for closing a 2015 CAPA on seven lots of envelopes that were out of specification for drug content without taking action because three out-of-specification results had a “suspected common root cause.” The company’s form for nonconformance procedures doesn’t require it to verify or validate the effectiveness of CAPAs being documented.