This publication provides a summary and analysis of publicly available yearly
observation data for drug product manufacturers from the U.S. FDA and presents
it in a more useful, digestible format. It includes an analysis of trends in
observations and a breakdown of the most common observations from the past five
Available to download. Prior to purchase please view the download
instructions and Terms of Usage.
Format: PDF (1 file 1.71
Table of Contents:
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- Summary of Drug FDA Observations
- Analysis of Drug FDA 483 Summary
- Available Resources
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.