Data Integrity Violations Draw Strong FDA Rebukes

Abstract

Falsified documents and manipulated test results prompt warnings and investigations. Because federal investigators cannot inspect every drug test site or production facility, FDA relies on manufacturers to submit complete and accurate information in all submissions and market applications, especially for innovative cell and gene therapies. FDA published final guidance in December 2018 for ensuring data integrity in compliance with current good manufacturing practices (CGMPs) (4), which emphasizes the importance of company top management establishing a "quality culture" that acknowledges the importance and value of data integrity in all aspects of drug development and production. According to press reports, FDA inspectors raised questions about a mouse essay at an inspection of a Novartis manufacturing facility in Illinois earlier this year, but company staff said they had been corrected.