In this webinar we will talk about the latest trends around FDA data integrity warning letters and citations.

We will discuss Karen Takahashi a Senior FDA Policy Advisor and how she recently noted that based upon a review of Warning Letters issued during the past two years, the most frequent citation was for failure to ensure that Lab records include:

“All tests necessary to assure compliance with established specifications and standards”

21 CFR 211.194(a)

This was in accordance with 21 CFR 211.194(a).

Ms. Takahashi further noted the following examples:

  • “Trial” sample injection data not retained as part of batch records
  • Sample weights, preparation and dilutions not being retained
  • Overwriting of data
  • Deletion of data detected in audit trails
  • Data found thrown away in the garbage