Guide to FDA Warning Letters

Warning Letters


The outcome of regulatory inspections is critical to an organization’s success. If the outcome of the inspection results in FDA 483 observations or a warning letter, it is important to take the observations and subsequent responses very seriously. This course discusses the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters, as well as providing essential elements of a thorough response. Additionally, this course reviews the proper structure of the response to ensure that the regulatory agency’s expectations are met and the submission process is properly understood.



Live Training (via GoToMeeting) will be offered in September – date/time info coming soon!

Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 3 hours
  • Skill level All levels
  • Wet Lab No
  • Max Students 16
  • Assessments Yes