FDA 483 - Flex Operating Room, LLC - June 18, 2019

An FDA inspection of Flex Operating Room, LLC, a medical device specification developer in Pittsford, NY, revealed significant deficiencies in their quality system. The firm failed to establish numerous required procedures, including those for design control, quality audits, management review, CAPA, nonconforming product, document control, and training. These widespread procedural gaps indicate a fundamental lack of a robust quality system for medical device development.