This article represents the third year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Articles for 2015 and 2016 may be found HERE and HERE . Failures in data integrity and data governance is an enforcement area that began almost twenty years ago and continues to increase in visibility and number of warning letter enforcement actions. FDA is not the only health authority that identifies these issues in inspections and enforcement actions, but FDA’s transparency ensures these data are readily available. In this summary we:
- Briefly review the history that serves as background to where we are now,
- Identify CY2017 warning letters that cite data integrity deficiencies,
- Identify the number of warning letters citing this topic in the past 10 years and the country location of these sites,
- Identify the regulations cited most frequently in CY2017 Drug GMP warning letters citing data integrity failure
- Provide specific text in warning letters associated with data integrity deficiencies READ MORE…..