FDA 483 - Vasomedical Inc - December 16, 2019

An FDA inspection of Vasomedical Inc, a medical device manufacturer in Plainview, NY, revealed significant deficiencies in its quality system, specifically concerning complaint handling and corrective and preventive action procedures. The firm failed to adequately review and investigate all complaints, including device failures potentially related to patient issues. Furthermore, the procedures for managing complaints were found to be inadequate, leading to inconsistent and untimely processing, with these issues being repeat observations from a previous inspection.