Data shows that more than half of all FDA recalls of medical devices have been caused by packaging and/or labeling errors.
- 90% of recalls relating to packaging and labeling in pharmaceuticals are attributed to human error (source: Pharmachem Skillsnet & Pharma Chemical Ireland Conference, 2009)
- Recalls relating to labeling errors for medical equipment had a 581% cumulative increase between 2010-2014. Those relating specifically to medical device labeling errors accounted for an average of 488 issues annually. (source: Blue Lynx Consulting, 2015)
- In the US, during Q3 2017, mislabeling was the cause of c.16% of pharmaceutical recalls, and c.14% of medical device recalls. (source: Stericycle Expert Solutions, Recall Index, Q3 2017)
What is the best way to react to an FDA recall? Make sure you are compliant not only by fixing the recall issue, but preparing for the future.
A broader view of your labeling procedures is essential. In the battle to deliver safe, accurate and compliant product information, it’s not just about the quality of the label – it’s also about the data.
By implementing a lifecycle label management solution supported with up to date validation documentation based on the GAMP 5 Model, you can ensure peace of mind.
We have extensive knowledge in the Medical Device industry; our solutions are designed by working with our clients and thought leaders to understand and resolve root cause non-compliance.
Whether the reason for recall is: labeling design, labeling change control, labeling false and misleading or labeling mix-ups, we can help you fix the issue and make sure you don’t have a recall again.
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