Speaker 1: If you're a medical device manufacturer selling in the U.S., there's a good chance you'll eventually receive notification that the FDA will be dropping by to conduct an inspection. The FDA's Office of Regulatory Affairs conducts nearly 2,000 facility visits each year. About 20% of those inspections are done outside the U.S. But don't panic. FDA inspections happen all the time. While we don't cover the specifics of FDA regulatory compliance in this video, we will give you some tips on how to prepare for an FDA inspection. Regardless, whether you make a low-risk or high-risk device, you need to be in compliance with 21 CFR Part 820, the FDA Quality System Regulation. If you're not prepared, the FDA could issue a Form 483 inspection report with minor or major findings. Failure to adequately address these findings in a timely manner could lead to a warning letter. That could mean real trouble for your company. Immediately, after learning of an impending FDA inspection, you need to get the word out. Inform your entire staff that an FDA inspection is coming. Be sure to provide the dates the FDA inspector will be on site. There are key individuals who should be available during the FDA inspection. Just email a big group, call those individuals, and make sure they will be present. Next, you need to ensure that everyone is familiar with how to interact with the FDA

Speaker 2: inspector.

Speaker 1: Make arrangements to have a comfortable, well-equipped, and controllable meeting room for the FDA to conduct their inspection. Comfortable for the inspector, and controllable so the traffic is minimized. Choose someone from your staff to be the FDA's point of contact. This person should be a senior member of your quality team, since they're the best qualified

Speaker 2: to answer questions the FDA inspector might have.

Speaker 1: There's a good chance the inspector will need to speak with various senior managers. It's a good idea to have them block out some time on their calendars for this event. Remember, when an FDA inspector's on site, they take priority over everything else. Make sure key management will be available on a moment's notice. Collect all relevant paperwork and documentation for your quality management system. Don't wait to look it up until asked. Make sure it's neat and organized and ready to hand over. Along with senior management, the FDA inspector might call upon your organization's subject matter experts for interviews. Get some coaching to them on how to handle their interaction with the inspector. Hopefully you've been conducting mock inspections and interviews as part of your quality management system. Regardless, it's still a good idea to brush up on interview techniques before the inspection. The most important thing you can do is relax. There will likely be some non-conformities discovered in the inspection that you'll have to address. You'll be given an opportunity to discuss the findings and will be provided a timeline for addressing them. It's very important that you address the findings within the allotted time frame or the FDA might issue a warning letter. That's very serious and you want to avoid this at all costs. Click the button at the very end of this video to download our full white paper that covers these tips and more. And for all of your medical device needs in the U.S., be sure to visit our website, www.emergogroup.com forward slash USA.