FDA Warning Letters: Analysis and Guidance (Hardcover)

Feb 2020
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The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.

In addition to the Warning Letter summaries there is discussion of U.S. FDA's authority to perform and approach to inspections, some analysis of the types of observations, and guidance on how to deal with adverse findings if you have them.

As an added benefit, this text also includes instructions and suggestions for those who were unable to avoid getting a warning letter to help resolve matters as quickly as possible.

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Introduction
  2. Why can FDA Inspect my Plant?
  3. FDA's Approach to Inspections
  4. Evaluating Your Facility for Compliance
  5. Overview of Warning Letter Observations
  6. Analysis of Warning Letters
  7. Avoiding and Responding to Warning Letters

Appendix 1: The Top 10 FDA 483s from FY 2019

Appendix 2: Typical Pre-Inspection Expectations from an FDA Inspector

About the Authors

About the Author

Jeanne Moldenhauer, Excellent Pharma Consulting, LLC has over 30 years of experience in the pharmaceutical industry. She is past chair of PDA's Environmental Monitoring/Microbiology Interest Group. Served on the Scientific Advisory Board of PDA, founded the Rapid Microbiology Users Group™ and is a member of ASQ and RAPS. She is the author of numerous journal articles and texts co-published by PDA and DHI: Steam Sterilization: A Practitioner's Guide, Laboratory Validation: A Practitioner's Guide and has edited and contributed to many volumes including the successful Environmental Monitoring book series, the Contamination Control series with Russell L. Madsen, Rapid Sterility Testing with Margarita Gomez and many other texts.