FDA Continues to Highlight Data Integrity as a QC Lab Issue
FDA warning letters issued between January and May 2024 continue to highlight the issue of ensuring data integrity within laboratories. As an example the warning letter to Westward Laboratories LLC, issued 14 May 2024, stated:
“… your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance with Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.”
