Abstract
The current regulatory climate is intense as the U.S. Food & Drug Administration (FDA) has ratcheted up their compliance oversight with more 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 twelve months. We will analyze the best Warning Letter examples and discuss best practices that can avoid these violations. With this knowledge, we can learn from these violations and ensure that your metrology program does not negatively impact the cost of quality of your organization.
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