Anatomy of an FDA Inspection

Get an inside look at FDA inspections from an administration official.

Members-Only Webinar

Thursday, January 30, 2020

1:00 – 2:00 p.m. EST

Join a representative from FDA’s Office of Regulatory Affairs for an explanation of how the administration selects firms for inspection, how inspectors prepare for inspections and the format of inspections.

What You’ll Learn

The webinar will cover the communications of findings from inspections. In addition, it will explore the path by which observations end up on Form 483 and when a written warning letter is warranted and issued. The presenter will cover the process of escalating inspection findings, when these findings should be escalated and how to resolve issues during an inspection. The webinar will conclude with helpful tips in responding to FDA Form 483.

Key Takeaways

  • FDA’s approach to inspections under FSMA and what to expect during the process.
  • The process for escalating areas of disagreement during an inspection.
  • How to respond to FDA Form 483.

FDA Speaker

Joann Givens

Director, Office of Human and Animal Food Operations-West

U.S. Food and Drug Administration