FDA 483 - Corindus Inc - July 27, 2021

Corindus Inc, a medical device manufacturer in Waltham, MA, was inspected by the FDA from July 21-27, 2021. The inspection revealed significant deficiencies in the documentation of corrective and preventive action (CAPA) activities. Specifically, the firm failed to adequately document root cause analyses, investigations, and verification of effectiveness criteria for multiple CAPAs.