Data Integrity In FDA Regulated Laboratories

Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data which is submitted to the Agency is both reliable and accurate.

The first indications of data integrity issues in the pharmaceutical industry began in the 1980’s, with the revelation that several generic drug manufacturers had submitted fraudulent data to the FDA on their Abbreviated New Drug Applications (ANDAs). Some of these generic drug manufacturers even went so far as to repackage name brand drugs as samples of their own products before submitting them for bioequivalency tests.

While this generic drug scandal put the issue of data integrity on the FDA’s radar, it was not until the year 2000 that the FDA issued its first warning letter to a pharmaceutical company for data integrity violations. An abundance of FDA warning letters and form 483 observations related to data integrity issues have been issued in the years since. In 2016 alone, the FDA issued 41 warning letters for data integrity and data governance deficiencies in pharmaceutical companies, 7 or which were in the United States. A recent analysis of 2016 warning letters by the FDAzilla Newsletter found that 80% of GMP-related warning letters issued to pharmaceutical companies based in the United States included a data integrity deficiency.