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.

Published by Jeremiah Genest

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

Published

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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