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In this video, you'll learn what we consider to be best practices when it comes to responding to an FDA warning letter. If you receive an FDA warning letter or a form 483, you don’t need to panic—but you do need to take it seriously. Follow these five best practices for responding. One: Respond on time. An FDA warning letter requires a response within 15 days. Two: Assign a response team. Your team should include your project team, management, and even your legal counsel. Three: Respond in the right format. Your response should address each issue separately, as it is listed in your warning letter. Four: Identify the root causes. Take the time to thoroughly investigate the underlying causes of each finding. Five: Develop corrective action plans. The most important thing you can do is have a plan to avoid making the same mistakes. That might include bringing in a third party to oversee your clinical trial. iMarc research can help you avoid another warning letter. Our comprehensive monitoring services bring a second set of critical eyes to your sites, ensuring your processes and documents are flawless. We can conduct audits to help your team ace your next inspection And we offer a full catalog of clinical research training courses your team can take at their convenience. Call us before the FDA calls you. request a consultation today. Contact Us Today To Learn More Let's talk about how we can help you keep your trial on track. FOR MORE INFORMATION ON CLINICAL TRIAL MONITORING: https://www.imarcresearch.com/clinica... FOR MORE INFORMATION ON CLINICAL RESEARCH SERVICES: https://www.imarcresearch.com/clinica... FOR MORE INFORMATION ON IMARC: https://www.imarcresearch.com/ #fdawarningletter #fdawarningletter2020 #clinicalresearch