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, at the Regulatory Affairs Professionals Society (RAPS) Utah Chapter webcast on June 16, 2020. More than 140 regulatory professionals attended the session.
The webcast 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. Panelists also discussed the potential product liability issues resulting from a 483 report.
Watch the full RAPS Utah Chapter webcast session here: Legal Aspects of FDA Regulatory Compliance: Preparing for an FDA Facility Inspection and Responding to a 483 Letter.