Masters Thesis

Correlation between inadequate process validations and FDA warning letters in the medical device industry

Poor quality medical devices may lead to dire financial and reputational consequences for an organization. Food and Drug Administration (FDA) warning letters are indicators of the challenges the medical device industry has to overcome the deficiencies. Process validation is a crucial element of the quality system within the medical device industry. When considering the number of FDA process validation issues which were uncovered between 2014 to 2018, the percentage of violations decreased significantly from 90.77 to 85.29%. However, procedural violations accounted for 100% of warning letters drafted during or before September 2018. Addressing issues at the design and process validation phase could greatly improve overall quality assurance, and potentially lead to fewer recalls, FDA warning letters, manufacturing issues, and related financial and/or reputational risks for the medical device industry.