Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007-2018.

Although the number of warning letters has decreased over the past decade and inspection results have been improving, there are still significant data integrity and other regulatory compliance issues found in the premarket side of the pharmaceutical industry. It is unclear if the reduction of warning letters is due to improved compliance in the industry or other factors unrelated to compliance.