FDA 483 data

quality intelligence 1 Minute

The FDA has posted the 2019 483 observations as an excel file. The FDA has made these files available every year since 2006 and I find them to be one of my favorite tools for evaluating regulatory trends.

So for example, looking at change related 483 I see:

2019 vs 2018 483 comparison for short description including “change”

Or for data integrity issues:

2019 vs 2018 483 comparison for short description including “data”

Very useful resource that should be in the bookmarks for every pharmaceutical quality professional.

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Published by Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

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2 thoughts on “FDA 483 data”

  1. Pingback: 2020 FDA 483s around change – Investigations of a Dog
  2. Pingback: MHRA 2019 GMP Inspection Data and Documentation observations – Investigations of a Dog

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