Develop a Strategy to Ensure Compliant Labeling Inspection

With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it’s time for manufacturers to rethink their approach to labeling inspection.

Despite the continual tightening of regulations around the packaging and labeling of medical devices, global device manufacturers continue to persist with traditional approaches to and infrastructure for labeling. The result is that the annual volume of medical device recalls remains consistent and the implications for cost, reputation, and—at the worse extreme—patient safety are as significant as ever.

Data show that more than half of all FDA recalls of medical devices since the first quarter of 2014 have been caused by packaging and/or labeling error. Given this, and with FDA starting to crack down on organizations that do not comply with its Quality System Regulations, medical device manufacturers must start treating compliant labeling inspection as business critical.