FDA 483 - Unetixs Vascular, Inc. - September 16, 2022

An FDA inspection of Unetixs Vascular, Inc. in Warwick, RI, from September 12-16, 2022, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for handling and investigating customer complaints, with hundreds of complaints remaining uninvestigated. Additionally, the firm failed to adequately control nonconforming products, specifically lacking proper investigation into the root cause of nonconformities.