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Preparing for an FDA Facility Inspection and Responding to a 483 Letter

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.


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