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5 Year Summary of FDA Medical Device 483s: 2015-2019 (single user digital version)

5 Year Summary of FDA Medical Device 483s: 2015-2019 (single user digital version)

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  • Description
  • Table of Contents
  • Author's Bio

The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of medical device manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more useful, digestible format. It also includes analysis into the observations of device products for the past five years including trend observations and a breakdown of the most common observations.

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Format: PDF (1 file 0.99 MB)

Table of Contents:

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  1. Introduction
  2. Summary of Medical Device FDA Observations
  3. Analysis of Medical Device FDA 483 Summary
  4. 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.

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