Viant AS&O Holdings, LLC – FDA 483, Oct 23, 2020

Viant AS&O Holdings, LLC, a medical device manufacturer in Orchard Park, NY, received two observations during an FDA inspection. The firm was cited for inadequate procedures to control nonconforming product, which was a repeat observation, and for failing to validate software used in the production of finished medical devices. These findings highlight deficiencies in the firm's quality system and manufacturing process controls.