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