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.

DISCLAIMER

Unless you are a current client of Holland & Hart LLP, please do not send any confidential information by email. If you are not a current client and send an email to an individual at Holland & Hart LLP, you acknowledge that we have no obligation to maintain the confidentiality of any information you submit to us, unless we have already agreed to represent you or we later agree to do so. Thus, we may represent a party adverse to you, even if the information you submit to us could be used against you in a matter, and even if you submitted it in a good faith effort to retain us.