FDA 483 - SteriGear, LLC - March 22, 2023

SteriGear, LLC, a medical device specification developer in Pleasant Grove, UT, received a Form FDA 483 with two observations. The inspection revealed deficiencies in complaint handling, specifically regarding the investigation and documentation of issues with their Fig Leaf urinary drainage collection device. Additionally, the firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, with undocumented performance evaluations for their contract manufacturer.