Top 10 Audit Findings and Ways to Get a Warning Letter


60 minutes

Course Overview

In this one-hour course, we will discuss the latest trends in FDA observations during their inspections of dietary supplement manufacturers. Discuss the top ten items that manufacturers are cited for, to help you in mitigating your risk and identifying non-conformances ahead of time. At the conclusion of this training participants will have an understanding of:
  • How to use the Code of Federal Regulations, pharmacopoeias and guidance documents as source information.
  • Who is the FDA and what power do they have?
  • How the FDA communicates with the company and how you should communicate with the FDA.
  • The top 10 items that dietary supplements manufacturers are cited for and — most importantly — the steps you can take to avoid each one of them!