Weekly Warning Letters

Weekly warning letters that are published demonstrate that the FDA is aggressively inspecting for data integrity issues and is reacting harshly to any signs of gaps in data integrity.

Senior FDA Advisor

Karen Takahashi, a senior FDA advisor, provided a comment on topic stating:

“Data Integrity problems break trust. In the time between inspections we trust you to do the right thing. If we finish an inspection and that trust has been broken, then we need to go through a few exercises to build that trust again before we can go forward and trust you until the next inspection.”

Warning Letter

Data integrity problems are the type of issue that changes a routine GMP observation or citation into an actual warning letter from the FDA.

Trust Easy to Lose

The trust of health authorities trust is difficult to gain, easy to lose, and takes years to rebuild once lost.

Now that we understand how seriously the FDA takes data integrity, let’s discuss some of the FDA’s expectations in this area.

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