Pharmaceutical and biotechnology companies are no strangers to FDA 483s and warning letters. In fact, the categories of Devices and Drugs accounted for the second- and third-most 483s issued by the FDA in 2019. Although not the top source of 483s, issues related to data integrity were responsible for a significant portion of 483s in these categories as well as in the growing field of Biologics.
Companies that can identify, remediate, and prevent data integrity issues will have a distinct advantage over those that continue to let data and procedures go unchecked. Download this white paper to learn five ways to address data integrity and process issues to minimize 483s and warning letters.