FDA 483 - Xodus Medical Inc - August 14, 2019

An FDA inspection of Xodus Medical Inc. in New Kensington, PA, revealed significant quality system deficiencies. The firm failed to adequately review and revalidate processes after changes, properly investigate complaints and Returned Goods Authorizations (RGAs), and control nonconforming products. These issues led to the distribution of devices with unsealed packaging and a lack of documented corrective and preventive actions.