FDA 483 - Medtronic Puerto Rico Operations Co. - August 29, 2017

An FDA inspection conducted from August 16 to August 29, 2017, identified a significant observation regarding inadequate corrective and preventive action (CAPA) procedures at a medical device firm. The primary concern was the lack of established interim controls to prevent the recurrence of identified problems before final corrective actions are implemented.

Specifically, the inspection highlighted issues with CAPAs initiated in April and August 2014 concerning discrepancies between sensor glucose and blood glucose readings for the Enlite Sensor MMT-7008 used with Paradigm and Next Generation 630G pumps. The root cause was identified as "sensor pull out," potentially leading to loss of function and data corruption.

Despite identifying sensor pull-out as the primary root cause, the initial April 2014 CAPA focused on training and educational changes rather than the physical issue. A subsequent August 2014 CAPA proposed revising product instructions to include additional adhesive as a corrective action. However, neither of these proposed corrective actions had been implemented by the time of the 2017 inspection, and no interim controls were put in place. This inaction occurred despite a record of (5)4 similar complaints received between 2014 and 2017.

The regulatory framework underpinning this observation is the FDA's quality system requirements, emphasizing robust CAPA processes. The firm is required to establish and effectively implement adequate CAPA procedures, including interim controls, and finalize long-standing corrective actions to address identified product performance issues and prevent recurrence.