Holland & Hart partners Kristy Kimball, Lee Gray, and Brent Johnson discussed legal aspects of FDA regulatory compliance, including preparing for an FDA facility inspection and responding to a 483 letter, via webinar for Celesq on September 1, 2020.
The webinar covered numerous aspects of preparing drug or medical device establishments for a successful FDA facility inspection and strategies for responding to any post-inspection 483 letters. Presenters also discussed the potential product liability issues resulting from a 483 report.
The presentation is available here.