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How to Respond to FDA Form 483s and Warning Letters

FDA issues hundreds of Form 483s and dozens of warning letters annually. What should you do if one shows up on your desk?

There are many reasons medical device manufacturers receive FDA warning letters, but the root cause often boils down to one thing: manufacturers weren’t prepared to respond to observations cited on the FDA’s Form 483.

In 2015, the FDA conducted 1,484 U.S. medical device inspections, with about half resulting in a dreaded 483.

Manufacturers have just 15 business days to fully address the inspection findings, evaluate the root causes and identify short-term and long-term corrective actions with realistic milestones and timelines. It’s a challenging demand and an area where many manufacturers fall short.

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How to Respond to FDA Form 483s and Warning Letters

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