Best Lessons Learned from FDA Warning Letters

Over the past five years, the U.S. Food & Drug Administration (FDA) has intensified their compliance oversight with increased Quality System Surveillance Inspections and increased Warning Letters being sent to Healthcare companies. Warning Letters are issued only for violations of regulatory significance. The good news is that the FDA publishes all Warning Letters on their web site as a public service. And they have a very easy search engine that allows you to find Warning Letters that contain topics particular to your industry or job. This paper reviews calibration related FDA Warning Letters generated over the past five years to select the best ten examples. We will analyze the best Warning Letter examples and discuss best practices that would avoid these violations. With this knowledge, we can learn from these violations and ensure that our metrology programs do not negatively impact the cost of quality of our organizations.