FDA 483 - Viant AS&O Holdings, LLC - October 27, 2023

An FDA inspection of Viant AS&O Holdings, LLC, a medical device contract manufacturer in Orchard Park, NY, revealed three significant observations. The firm was cited for inadequate process validation for a product family, insufficient control procedures for nonconforming products, and failures in establishing adequate procedures for purchased products and services, specifically regarding supplier reviews. These issues indicate deficiencies in the firm's quality system.